MAUDE Adverse Event Report: Philips North America LLC HeartStart XL+ Defibrillator/Monitor

Model Number	861290
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the heartstart xl+ defibrillator indicating that a therapy disabled message was being emitted suggesting a fault in the therapy pca.There was no patient involvement.
Additional Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
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 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 (b)(6), 2017.The end of life (eol) ended (b)(6)2022, where the end of support (eos) period began.The customer was informed the device is eol and they removed it from service.Based on the information available and the testing conducted, the cause of the reported problem was not determined.Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received the complaint file will be reopened.

• 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: maria heiling ; 22100 bothell everett highway; bothell, WA 98021 ; +1(909)570-3538
• MDR Report Key: 50406148
• Report Number: 3030677-2026-100905
• Device Sequence Number: 13375719
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: (01)00884838023680
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2026

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
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2013
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown