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

Model Number M3536A

Device Problems Device Alarm System (1012); Electrical /Electronic Property Problem (1198)

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

Event Date 07/08/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device had a indicator problem.There was no patient involvement.

Manufacturer Narrative

Updated device problem code grid.

Event Description

It was reported to philips, that the device had a indicator problem.The customer requested, that a philips field service engineer (fse) be dispatched to the customer site.The reported issue was confirmed.And traced to a faulty power pca.Replacement of the pca power board.The external power supply module was not replaced, because it dates from april 2021.The delivered one was left with the manager.Upon conclusion of the evaluation.It was determined, that this was a malfunction of the power pca.The power pca was replaced to resolve the reported issue.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
• Manufacturer (Section G): PHILIPS NORTH AMERICA LLC; 22100 bothell everett highway; bothell WA 98021
• Manufacturer Contact: dana tackett ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12264492
• MDR Text Key: 264699875
• Report Number: 3030677-2021-13347
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• 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: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/08/2021
• Initial Date Manufacturer Received: 07/08/2021
• Initial Date FDA Received: 08/02/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/21/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1