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

Model Number 861290

Device Problems Battery Problem (2885); Complete Loss of Power (4015)

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

Event Date 05/15/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported the device had battery issues.There was no patient involvement.

Manufacturer Narrative

Philips received a complaint on the heartstart xl+ indicating that there was no power.There was no reported patient involvement.A philips field service engineer (fse) evaluated the device on site and confirmed the reported issue.However, it was determined the device was end of life.The customer was informed that service could no longer be completed on the unit as the device had reached end of life (eol).Philips has made the decision to discontinue the heartstart xl+ monitor/defibrillator, which has reached the end of its product life cycle.The last date of shipment for the heartstart xl+ was october, 2017.The end of life (eol) is scheduled globally to end 12/31/2022, where the end of support (eos) period will then begin.As troubleshooting was not completed for the device, a cause could not be established.The customer was made aware of the end of life terms and the device remains at the customer site.No further action is warranted at this time.

• 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: sara carlson ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 17093388
• MDR Text Key: 317140788
• Report Number: 3030677-2023-02292
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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

• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 05/15/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2014
• 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