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

Model Number	M3535A
Medical Device Problem Code	Failure to Deliver Shock/Stimulation (1133)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the defibrillator indicating that the device had discharge fault in bootup self test.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: 50927544
• Report Number: 3030677-2026-101038
• Device Sequence Number: 10725277
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: (01)00884838000018
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 09/29/2026

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: 09/11/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2014
• 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