MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problem Failure to Read Input Signal (1581)

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

Event Date 07/09/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device failed to recognize the installed therapy cable.There was no patient involvement.

Event Description

It was reported to philips that the device failed to recognize the installed therapy cable.The customer requested that an authorized field service engineer (fse) be dispatched to the customer site.Upon evaluation of the device, the reported issue was confirmed and it was determined that the therapy cable and/or trunk cable would need to be replaced to return the device to working condition.Based on the conclusion of the evaluation, it was determined that both the therapy cable and trunk cable needed to be replaced to resolve the noted issue.Both components were replaced and the device was deemed fit for use.As multiple component were installed to repair the device, a definitive cause for the failure could not be determined.The device remains at the customer site.There is no indication of a systemic problem.No further investigation or action is warranted.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 12266483
• MDR Text Key: 264712211
• Report Number: 3030677-2021-13354
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• Combination Product (y/n): N
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/09/2021
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1