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

Model Number	861290
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based on information provided by philips remote service engineer (rse) and has been investigated by the philips complaint handling team.It was determined the device has reached end of life, and neither service nor spare parts are no longer provided.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.The device remains at the customer site, requiring no further evaluation.Based on the information available and the testing conducted, the cause of the reported problem was not determined.The device is eol.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.
Event or Problem Description
Philips received a complaint on the heartstart xl+ defibrillator/monitor indicating that the device failed therapy delivery test.There was no patient involvement.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Common Device Name: 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: syed zaheer ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 25534042
• Report Number: 3030677-2026-100663
• Device Sequence Number: 9670932
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: (01)00884838023680
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K110825
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/17/2026

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
• Operator of Device: Other
• Device Model Number: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2026
• Initial Report FDA Received Date: 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2014
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown