MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR; DEFIBRILATOR

Model Number 861290

Device Problem Peeled/Delaminated (1454)

Patient Problem Arrhythmia (1721)

Event Date 02/16/2022

Event Type  malfunction  

Event Description

It was reported to philips that during long-term monitoring (8-10 hours) for an arrhythmia diagnosis, the pads partially detached from the patient.The defibrillation pads were on for safety and monitoring only unless defibrillation was necessary.During the treatment/ diagnosis, the staff noticed that the electrodes began to release from the patient's skin.The staff just pressed the pads back on and kept working.There was no harm or injury to the patient.

Manufacturer Narrative

One set of pads in a new, unopened package from the same lot number were returned for failure analysis.The report problem was unable to be verified.The allegation according to which these ¿pads detach from patient¿ could be, in a way, interpreted as weak adhesive/gel to the pads.Such allegation was not verified with these pads received new and in an unopened pouch.The pads tested fine and reported no issues.These pads were received new, never used, and in a no fault found state.Upon conclusion of the evaluation, the new pads were found to be fully functional.At this point in time, philips is unable to rule out that a malfunction did not occur as the pads used during the event were discarded.As the issue could not be replicated during evaluation, a definitive cause for the alleged failure could not be determined.The device passed all required testing and was deemed fit for use.The device remains at the customer site.The available information from this report does not support that this malfunction represents a systemic, design, or labeling problem.No further investigation or action is warranted.

Event Description

It was reported to philips that during long-term monitoring (8-10 hours) for an arrhythmia diagnosis, the pads partially detached from the patient.The defibrillation pads were on for safety and monitoring only unless defibrillation was necessary.During the treatment/ diagnosis, the staff noticed that the electrodes began to release from the patient's skin.The staff just pressed the pads back on and kept working.There was no harm or injury to the patient.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Type of Device: DEFIBRILATOR
• 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: kara grubbs ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 13620962
• MDR Text Key: 286333415
• Report Number: 3030677-2022-01264
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• 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: Health Professional
• Device Expiration Date: 04/19/2024
• Device Model Number: 861290
• Device Catalogue Number: 861290
• Device Lot Number: 211019-1807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 02/28/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1