MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX ALS MONITOR; DEFIBRILLATOR

Model Number	M3536A
Medical Device Problem Code	Failure of Device to Self-Test (2937)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based on information provided by philips authorized service engineer (asp) and has been investigated by the philips complaint handling team.The asp evaluated the device on-site and, using the alternative hands-free cable and test load, completed various tests¿including operational tests¿that the device passed.The device is fully functional.Based on the information available and the testing conducted, the cause of the reported problem was not determined.The device functions within its specification.
Event or Problem Description
Philips received a complaint on the heartstart mrx als monitor indicating that the device does not pass the functional test.There was no patient involvement.

• Brand Name: HEARTSTART MRX ALS MONITOR
• Common Device Name: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd; andover MA 01810
• Manufacturer Contact: tanya deschmidt ; 3000 minuteman rd; andover, MA 01810 ; 6172455900
• MDR Report Key: 24349858
• Report Number: 3030677-2026-100195
• Device Sequence Number: 11949361
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: (01)00884838006652
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K031187
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/16/2026

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: Health Professional
• Device Model Number: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2026
• Initial Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2010
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown