MAUDE Adverse Event Report: Philips North America LLC HeartStart MRx -EMS 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	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the defibrillator indicating that the system self-test not pass.There was no patient involvement.
Additional Manufacturer Narrative
(b)(6).

• Brand Name: HeartStart MRx -EMS Defibrillator
• 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: 50422697
• Report Number: 3030677-2026-100908
• Device Sequence Number: 13354781
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: (01)00884838006652
• 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): 08/25/2026

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: M3536A
• Device Catalogue Number: M3536A
• 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: 08/12/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/13/2011
• 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