MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART; AED

Model Number SMART PADS III

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2023

Event Type  malfunction  

Event Description

It has been reported to philips that at least 12 packs of pads failed due to adhesive on pad not sticking to patient and peeling away from the pad itself.

Manufacturer Narrative

This reported problem code combination and specific scenario was assessed by a post-market surveillance clinical expert and the assessment is as follows: philips aed defibrillation pads are designed with a water-based gel which improves the electrical conductivity between the aed and the patient¿s chest wall.There may be times when the user observes that the gel has an unexpected appearance: gel appears to be melted, sticky, discolored, or dissolved.This appearance would not be obvious until the foil packaging was removed.The user should use a spare pad cartridge if available.If no spare pad cartridge is available, the user should not delay in administering cpr and delivering shock therapy and should use the pads as instructed no matter what the state of the pads are.Philips devices incorporates design mitigations to aid the user.If the pads are in fact unusable due to being sticky, melted, discolored, etc., the device is designed to alert the user by delivering a voice guidance message(s) such as the following (wording may vary per product): press the pads firmly to the skin, insert new pads cartridge , the shock was not delivered.The product ifu/user manual also contains the following language regarding use of the defibrillation pads (wording may vary per product ifu): philips recommends that you store a spare pads cartridge and spare battery with your [device].The self-test includes pads readiness testing.In addition, it runs a pads self-test each time a pads cartridge is inserted.It alerts you if it finds a problem.In summary, the scenario of the pad gel having an unexpected appearance should not preclude the use of the device in delivering shock therapy.If the pads were in fact unusable due to the sticky or melted appearance, the user was appropriately alerted by an audible alarm (chirp/beep) and message(s) which indicates that the [aed] device worked as designed by alerting users to the need for device maintenance.1 given these considerations, this scenario is not likely to result in serious injury or harm to the user or patient should it recur.

• Brand Name: HEARTSTART
• Type of Device: AED
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 17692725
• MDR Text Key: 322763021
• Report Number: 3030677-2023-03536
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023765
• UDI-Public: 00884838023765
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: SMART PADS III
• Device Catalogue Number: 989803149981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 10/06/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1