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

Model Number M3535A

Device Problem Power Problem (3010)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2021

Event Type  malfunction  

Event Description

It was reported to philips that the ac module was no longer providing power to the device.There was no patient involvement.

Event Description

It was reported to philips that the ac module was no longer providing power to the device.There was no patient involvement.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• MDR Report Key: 11425231
• MDR Text Key: 238646848
• Report Number: 3030677-2021-10109
• 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: user facility
• Remedial Action: Replace
• 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: 02/10/2021
• Initial Date Manufacturer Received: 02/10/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 02/10/2021
• Supplement Dates FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-1923-2019
• Patient Sequence Number: 1