MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILLATOR

Model Number	861288
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report is based on information provided by the remote service engineer (rse) with an investigation documented by philips complaint handling.Remote service was provided by the rse which included confirming with the technicians on site that the pad cable was determined to be faulty and needed replaced.Based on the results of the analysis, it was determined the cause of the reported problem was with the pad cable; however, it is unknown specifically what caused the cable to be faulty.A replacement pad cable was ordered to resolve the reported issue.Based on the information available and results of additional analysis, no further action is necessary at this time.
Event or Problem Description
Philips received a complaint on the heartstart mrx indicating that the hands-free pad cable was faulty.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: syed zaheer ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 25760908
• Report Number: 3030677-2026-100724
• Device Sequence Number: 21456974
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/09/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2008
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown