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

Model Number	861288
Medical Device Problem Code	Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Philips received a complaint on the heartstart mrx monitor/defibrillator indicating the device can only be discharged by pressing the button, but not via the pads causing failure of the functional verification test.There was no patient involvement.
Additional Manufacturer Narrative
This report is based on information provided by philips remote service engineer (rse) and has been investigated by the philips complaint handling team.The rse determined that this model is out of support, and the spare parts are no longer available due to end of life.The customer will be informed that service can no longer be completed on the unit as the device has reached end of life (eol).The heartstart mrx device and all associated service/support was discontinued on (b)(6) 2022.The device remains at the customer site, requiring no further evaluation.Based on the information available and the testing conducted, the cause of the reported problem was not determined.The customer will be informed that service can no longer be completed on the unit as the device has reached end of life (eol).Based on the information available and results of additional analysis, no further action is necessary at this time.If additional information is received the complaint file will be reopened.

• 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: 50192019
• Report Number: 3030677-2026-100864
• Device Sequence Number: 21303972
• 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): 08/10/2026

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: Other
• Device Model Number: 861288
• 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: 08/03/2026
• Initial Report FDA Received Date: 08/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/13/2005
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown