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

Model Number 861290

Device Problem Failure to Discharge (1169)

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

Event Date 06/09/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device fails defibrillation test.There was no patient involvement.

Event Description

It was reported to philips, that the device fails defibrillation test.There was no patient involvement.The bench technician evaluated the device.Confirmed, the failing defibrillation test.The device needs a high voltage capacitator and a therapy pca.The therapy board was returned.And had failure analysis performed on it.The reported allegation about the "failing defib test " was not verified or duplicated, during lab tests.The therapy pca passed all tests, during operational check.And performed as expected.Therefore, there is no fault found (nff) with this therapy board it was determined, that the therapy pca and a high voltage capacitor require replacement.We are unable to determine, the root cause of the event as multiple parts were required for replacement.The parts were replaced.And the device passed all testing.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Type of Device: DEFIBRILLATOR
• 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: daniel derochers ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12107880
• MDR Text Key: 259635022
• Report Number: 3030677-2021-12662
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/09/2021
• Date Manufacturer Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2014
• 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