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) with an investigation documented by philips complaint handling.Remote service was provided which included the technician re-performing the functional test.No anomalies were found when performing the functional verification and the system was noted to meet specification and was returned to use.Based on the results of the analysis, the product was confirmed to be operating per specifications, and the reported issue could not be replicated.The issue was resolved by re-performing the functional test with positive results.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.
Event or Problem Description
Philips received a complaint on heartstart xl+ defibrillator indicating that the functional test failed.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: 25669172
• Report Number: 3030677-2026-100697
• Device Sequence Number: 10406543
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: (01)00884838023680
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 06/30/2026

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: 06/29/2026
• Initial Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/06/2016
• 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