MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR; RECHARGEABLE PROFESSIONAL AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	M3536A
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the heartstart mrx defibrillator indicating that the device needs a battery.The customer was informed that service could no longer be completed on the unit as the device had reached end of life (eol).The heartstart mrx device and all associated service/support was discontinued on (b)(6) 2022.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Common Device Name: RECHARGEABLE PROFESSIONAL AUTOMATED EXTERNAL DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; bothell everett highway 22100; bothell WA 98021
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; bothell everett highway 22100; bothell WA 98021
• Manufacturer Contact: tanya deschmidt ; bothell everett highway 22100; bothell, WA 98021 ; 4252051272
• MDR Report Key: 23898014
• Report Number: 3030677-2025-002733
• Device Sequence Number: 5129065
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: (01)00884838006652
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2025

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2025
• Initial Report FDA Received Date: 12/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2005
• 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