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

Model Number M3535A

Device Problems Failure of Device to Self-Test (2937); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/12/2021

Event Type  malfunction  

Event Description

It was reported that the device failed the defibrillation test.There was reportedly no patient involvement.

Event Description

It was reported that the defibrillation test failed.There was reportedly no patient involvement.The manufacturer's authorized field service engineer (fse) evaluated the device and confirmed the reported problem.Upon conclusion of the evaluation, it was determined that the therapy capacitor and patient connect assembly required replacement.We are unable to determine the root cause of the event as multiple parts were required for replacement.The device remains at the customer site and no further evaluation is warranted at this time.

• Brand Name: HEARTSTART MRX MONITOR/DEFIB
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 12284502
• MDR Text Key: 265286973
• Report Number: 3030677-2021-13398
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup

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 Operator: Health Professional
• Device Model Number: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/12/2021
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 07/20/2021
• Supplement Dates FDA Received: 10/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1