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

Model Number M3536A

Device Problem Failure to Run on Battery (1466)

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

Event Date 07/21/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device has a power fault due to a low battery.There was no patient involvement.

Event Description

It was reported to philips that the device has a power fault due to a low battery.The field service engineer (fse) evaluated the device and found the battery charge low.The battery needs to be replaced.It was determined that this was a malfunction of the battery.It was replaced and the device passed all performance assurance testing.The device remains at the customer site and no further evaluation is required at this time.

• 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: 12330751
• MDR Text Key: 266858538
• Report Number: 3030677-2021-13656
• 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: foreign,user facility
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• 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: 07/21/2021
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1