MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX AIRWORTHY; RECHARGEABLE PROFESSIONAL AUTOMATED EXTERNAL DEFIBRILLATOR

Model Number	M3536M
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the heartstart mrx device indicating that there was a battery problem.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 03-feb-2022.

• Brand Name: HEARTSTART MRX AIRWORTHY
• Common Device Name: RECHARGEABLE PROFESSIONAL AUTOMATED EXTERNAL 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 21547596
• Report Number: 3030677-2025-000755
• Device Sequence Number: 15217474
• Product Code: MKJ
• UDI-Device Identifier: 00884838006676
• UDI-Public: (01)00884838006676
• 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
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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: M3536M
• Device Catalogue Number: M3536M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2010
• 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