Medical Device Correction Notification
Philips M5071A (adult) and M5072A (infant/child) AED pads
Important information for the continued safe and proper use of your equipment
Philips is notifying customers of a potential issue with the Adult SMART Pads Cartridge (M5071A) and the Infant/Child SMART Pads Cartridge (M5072A) for use specifically with the HeartStart HS1 AEDs (including HeartStart Home and HeartStart OnSite). Your complimentary Adult SMART pads will be shipped to you by the end of 2023, if they have not been replaced already.
Philips has identified that for affected pads, some gel may fold onto itself, resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad to make contact with a patient’s skin.
If this occurs, the HS1 AED could deliver less effective or ineffective therapy. As affected pads are stored in sealed cartridges, this issue will not be visible until the cartridge is opened for use. Users should continue to use the HS1 AED and pads as-is and follow the device’s voice prompts during use. The AED will audibly guide users through each step of the procedure. It is recommended that customers and users keep their HS1 AED in service according to the Instructions for Use/Owner’s Urgent Medical Device Correction Letter/Field Safety Notice.
Philips has an updated Adult SMART pad that was cleared by the Food and Drug Administration (FDA) on February 2023. We began shipping updated Adult SMART pads globally in April 2023. As of November 14, 2023, we have manufactured approximately 1.8 million new pads.
Please take the following actions:
Key Points
Continue using the HS1 AED and pads as-is
During use, ensure the majority of the pad surface is covered with gel and apply the pads to the patient. If you notice the gel beginning to separate from the foam backing as you peel, try to prevent the gel from folding onto itself if possible. Do not hesitate to apply the pads to the patient unless the gel has almost completely separated from the backing. In case of trouble, install spare pads if available and continue the rescue. No matter the state of the pads, follow the voice prompts because the AED will walk you through the necessary actions.
Do not try to examine the pads' gel prior to patient use
It is not possible to know if your pads are affected by the problem prior to use because the pads are protected by a foil seal. The foil seal on the pads cartridge should be opened only for patient use in an emergency because the pads will quickly dry out if the foil seal is broken.
Replace with the new SMART pads
Once you receive the updated Adult or Infant/Child SMART pads cartridge, replace the current pads cartridge in your AED with the new one. The current pads cartridge LOT # starts with a Y, the updated pads cartridge starts with a C. Where to find the LOT #:
If your current pads cartridge has not expired, please keep the current pads cartridge and use it as a spare in case of emergency.
Philips recommends that you store a spare pads cartridge with your HS1 / OnSite / Home AED
If the current Adult or Infant/Child SMART pads cartridge is not expired, please keep it as a spare to use in an emergency only. If you need to change your pads in an emergency, there is a short video showing how to replace the pads cartridge at:
www.philips.com/replace-aed-pads
If the problem occurs and you do not have a spare pads cartridge, attend to the patient, providing CPR if needed, until Emergency Medical Services Personnel arrive.
If you have received an Urgent Medical
Device Correction/Communication,
here is what you need to do:
Device Correction/Communication,
here is what you need to do:
Please forward the notice to all those who need to be aware within your organization or to any organization where HS1/OnSite/Home AED devices or pads cartridges have been transferred, (if appropriate.)
Keep a copy of your letter with the Instructions for Use/Owner’s Manual of your HS1/OnSite/Home AED.
Verify your contact and AED information by following instructions on the communication you will be receiving.
Once you receive your updated Adult and/or Infant/Child SMART pads cartridge, install it into your HS1/OnSite/Home AED.
If your current pads cartridge with a LOT number beginning with “Y” has not expired, it may be kept with your HS1/OnSite/Home AED as a spare in case of an emergency only.
Questions and answers
- What devices are affected?
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Philips is issuing a Urgent Medical Device Correction Letter/Field Safety Notice regarding the Adult SMART Pads Cartridge [REF: M5071A] and the Infant/Child SMART Pads Cartridge [REF: M5072A] for use with the HeartStart HS1, HeartStart OnSite, and HeartStart Home Automated External Defibrillator (AED) devices. The HeartStart HS1, OnSite and Home AEDs are intended for use in public places or the home.
- Why do these devices require a correction?
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HS1/OnSite/Home AED pads (PN: M5071A, M5072A) have been observed to experience gel separation from the foam/tin backing when peeled from the yellow plastic liner. The gel may fold onto itself resulting in reduced surface area of gel on the pad, or it may separate almost completely leaving only a small amount of gel on the pad. Any pad currently installed in or stored with an HS1/OnSite/Home AED could experience this problem, and it is not possible to know prior to patient use if your pad is affected because the pads are protected by a foil seal. At the time of the issuance of the February 2022 notification, Philips has received 100 reports about this issue since 2010 out of approximately 5 million shipments of M5071A and M5072A pads. (Most of these reports, approximately 80, were received in 2021.)
- Are these devices being removed from service?
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No. Users should continue to use the HS1/OnSite/Home AED and pads as-is, and follow the device’s voice prompts during use, because the AED will audibly guide users through each step of the procedure. It is recommended that customers and users keep their HS1/OnSite/Home AED in service according to the Instructions for Use/Owner’s Manual and the Urgent Medical Device Correction Letter/Field Safety Notice.
- Is there a safety hazard with these devices?
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In the event of significant loss of gel, there is a possibility that the pad may not adhere correctly, or not make effective contact with a patient’s skin. Should this occur, there is a possibility of insufficient therapy delivery, or of patient skin burns. There is also the potential for delayed therapy, if the appearance of the peeled pad leads a user to not use affected pads and/or spend time searching for spare pads.
Users should continue to use the HS1/OnSite/Home AED and pads as-is, and follow the device’s voice prompts during use, because the AED will audibly guide users through each step of the procedure. It is recommended that customers and users keep their HS1/OnSite/Home AED in service according to the Instructions for Use/Owner’s Manual and the Urgent Medical Device Correction Letter/Field Safety Notice.
- How many devices are affected?
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Any HS1/OnSite/Home AED pad (PN:M5071A, M5072A) currently installed in or stored with an HS1/OnSite/HomeAED could experience this issue. It is not possible to know prior to patient use if a pad is affected because the pads are protected by a foil seal.
At the time of the February 2022 issuance of this notification, Philips has received approximately 100 reports about this issue out of approximately 5 million shipments of M5071A and M5072A pads since 2010. (Most of these reports, approximately 80, were received in 2021.)
IMPORTANT NOTE: The issue described in the Medical Device Correction/Field Service Notice does not affect the FRx device and pads.
- Does this issue affect the Philips indemnification obligation to users?
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No, this issue does not affect the Philips indemnification obligation to users.
- What should customers or users do? Should they stop using the devices?
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Users should continue to use the HS1/OnSite/Home AED and pads as-is, and follow the device’s voice prompts during use, because the AED will audibly guide users through each step of the procedure. It is recommended that customers and users keep their HS1/OnSite/Home AED in service according to the Instructions for Use/Owner’s Manual and the Urgent Medical Device Correction Letter/Field Safety Notice.
- What should customers do if there seems to be something wrong with a pad’s appearance?
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A discolored, melted appearance does not have any impact on the delivery of therapy; however, there may be a delay of therapy if the user hesitates to apply the pad due to its appearance.
Do not hesitate to apply discolored, melted pads to the patient unless the gel has almost completely separated from the backing. No matter the state of the pads, the HS1 AED will audibly prompt the user through each step of the procedure.
- Should I store a spare pads cartridge with my HS1/OnSite/Home AED?
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As described in the Instructions For Use (IFU), it is recommended that you store a spare pads cartridge with your HS1/OnSite/Home AED. A short video showing how to replace the pads cartridge can be found at: www.philips.com/replace-aed-pads-video
- How do I replace pads cartridges on the HS1, OnSite, and Home AEDs?
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Locate the latch at the top edge of the AED and slide it to the side. The SMART pads cartridge will be released. Lift out the used SMART pads cartridge. Insert the bottom end of the new SMART Pads cartridge into the recess, then press in the cartridge until the latch clicks into place. You can view a short video showing how to replace the pads cartridge at the following web address. www.philips.com/replace-aed-pads-video
- What has Philips done to correct the issue?
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Philips has updated the Adult and Infant/Child SMART pads and has been cleared by Competent Authorities worldwide.
- When will a correction for this issue be ready?
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Updated Adult and Infant/Child SMART pads have been cleared by the FDA. We have been shipping replacement pads since April 2023. If you have not received your replacement pad, please contact your local Philips Representative, or call Philips at (800) 263-3342.
- Does this issue affect other Philips defibrillator products?
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No, this issue only affects Adult SMART Pads Cartridge [REF: M5071A] and the Infant/Child SMART Pads Cartridge [REF: M5072A] for use with the HeartStart HS1, HeartStart OnSite, and HeartStart Home Automated External Defibrillator (AED) devices.
The issue described in the Medical Device Correction/Field Service Notice does not affect the Philips FRx device and pads. Philips continues to fulfill orders for the FRx AED and accessories including SMART Pads II.
- Has this issue been reported to the FDA or other regulators?
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The relevant regulatory authorities were notified of this issue in February 2022.
- How will I receive my Adult SMART pads cartridge?
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We have been shipping replacement SMART pads since April 2023. If you have not received your replacement pads, we may not have correct information from you. Please contact your local Philips Representative, or call Philips at (800) 263-3342.
- How many Adult SMART pads cartridges will I receive?
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Once you have verified your AED serial number and SMART pads LOT #, you will receive one (1) updated SMART pads cartridge per AED you own.
- How can I order additional Adult SMART pads?
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Please contact your local Philips representative, or customers may call Philips at (800) 263-3342.
- If I use the AED, can I put the current pads back in for use?
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If you use the AED, immediately reorder a set of pads through your Philips representative. In an emergency, while you are waiting for the ordered pads to arrive, you can use the original pads.
- What should I do if I have an HS1/OnSite/Home AED but have not heard from Philips or a distributor?
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Owners of the HS1/OnSite Home AED who have not received a letter from Philips or a distributor by the end of March 2022 may contact Philips or their local Philips Representative, or customers may call Philips at (800) 263-3342.
- What should I do if I am aware of an impacted Philips device in my facility, but I am not the original purchaser?
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Philips or a Philips Distributor will send a letter to the customer of record. Please make a note of the Serial Number(s) of your HS1/OnSite/Home AED(s) and contact Philips or your local Philips Representative who will be able to tell you to whom the notification was sent, or customers may call Philips at (800) 263-3342.
- What should I do if I have permanently taken my HS1/OnSite/Home AED out of service?
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If you have permanently taken your HS1/OnSite/Home AED out of service, please make a note of the Serial Number(s) of the HS1/OnSite/Home AED(s) that were taken out of service if available and contact Philips or your local Philips Representative, or customers may call Philips at (800) 263-3342.
- What should I do if I have transferred ownership of my HS1/OnSite/Home AED?
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Please provide a copy of the Medical Device Correction letter with the new owner.
- When will the HS1/OnSite/Home resume shipping?
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The HS1/OnSite/Home AEDs have resumed shipping as of April 2023.
- Who can I contact if I have questions?
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Customers may contact their local Philips Representative as shown in the Medical Device Correction letter, or customers may call Philips at (800) 263-3342.
