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

Model Number M3535A

Device Problem Output below Specifications (3004)

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

Event Date 08/18/2021

Event Type  malfunction  

Event Description

It was reported to philips that the defibrillator is out of tolerance.There was no patient involvement.

Event Description

It was reported to philips that the defibrillator is out of tolerance.The device was received by bench for repair.The noted failure was identified during inspection of the device by an authorized bench technician.As a result of the issue, it was determined that the defibrillator capacitor would need to be replaced.Diagnostic performed by engineer: diagnostics of mrx defibrillator, serial number:(b)(6) performed in accordance with the service manual.No reported malfunction.During the tests, a reduced defibrillation power was found.Remaining functional tests were performed and ended with positive results.The device remains out of order - the condenser needs to be replaced in order to repair the device.Upon conclusion of the evaluation, it was determined that this was a malfunction of the defibrillator capacitor.The defibrillator capacitor was replaced to resolve the reported issue and the device was scheduled to be returned to the customer site.No further evaluation is required 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
• 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: 12443511
• MDR Text Key: 270492406
• Report Number: 3030677-2021-14193
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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

• Date FDA Received: 09/08/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/18/2021
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/22/2013
• 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