MAUDE Adverse Event Report: Philips North America LLC HeartStart MRx monitor/defib; Defibrillator

Model Number	M3535A
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	09/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
This report is based on information provided by philips authorized service provider (asp) with an investigation documented by philips complaint handling.Philips received a complaint on the heartstart mrx monitor/defib indicating that the functional test failed.There was no patient involvement.

• Brand Name: HeartStart MRx monitor/defib
• 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: 50941993
• Report Number: 3030677-2026-101049
• Device Sequence Number: 10735163
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: (01)00884838000018
• 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
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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
• Device Model Number: M3535A
• Device Catalogue Number: M3535A
• 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: 09/14/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/30/2012
• 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