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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).
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 is actively working on design changes to eliminate this issue in the Adult SMART Pads Cartridge and the Infant/Child SMART Pads Cartridge, and projects new pad availability later in 2022. Affected customers will be notified when the new design pad is available. This issue only relates to HeartStart HS1 AEDs (including HeartStart Home and HeartStart Onsite), and does not involve HeartStart FRx.
The Medical Device Correction advises customers to take the following actions:
Continue using the HS1 / OnSite / Home 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 step 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.
Philips recommends that you store a spare pads cartridge with your HS1 / OnSite / Home AED
Philips recommends that you store a spare pads cartridge with your HS1/OnSite/Home AED. If you need to change your pads in an emergency, there is a short video showing how to replace the pads cartridge at Philips' official website.
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/Field Safety Notice letter,
here is what you need to do:
- Please pass 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.
- Complete and return the reply form you received with your letter.
Questions and Answers: (click to see answers)
What devices are affected?
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?
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?
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?
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?
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.
What should customers or users do? Should they stop using the devices?
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?
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/OnSite/Home 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?
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 here
How do I replace pads cartridges on the HS1, OnSite, and Home AEDs?
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 here
How will Philips correct this issue?
Philips is working on changes intended to eliminate the issue in the M5071A and M5072A pads, including updates to production processes and changes to the pad composition.
When will a correction for this issue be ready?
Philips is working on changes intended to eliminate the issue in M5071A and M5072A pads. Philips expects to release updated pads later in 2022.
Does this issue affect other Philips defibrillator products?
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?
The relevant regulatory authorities were notified of this issue in February 2022.
Who can I contact if I have questions?
Customers may contact their local Philips Representative as shown in the Medical Device Correction letter. In the USA, customers may call Philips at (800) 263-3342.
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