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	09/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the defibrillator indicating that the device did not pass the operational check.There is no patient harm was reported.
Additional Manufacturer Narrative
Reporter first name: unknown reporter last name: (b)(6).Reporting institution name: (b)(6).Reporting address line 1:(b)(6) reporting address city: shenzhen reporting address postal:(b)(6) reporting institution phone #: (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: 50927539
• Report Number: 3030677-2026-101037
• Device Sequence Number: 10725275
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: M3536A
• Device Catalogue Number: M3536A
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/11/2012
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown