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

Model Number M3535A

Device Problems Failure of Device to Self-Test (2937); Data Problem (3196)

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

Event Date 06/21/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device experienced a general system test failure.There was no patient involvement.

Event Description

It was reported to philips that the device experienced a general system test failure.The customer requested that the device be returned for bench repair.The device was received by the bench repair service on 30-jun-2021.Upon evaluation of the device by an authorized bench technician, the reported issue was confirmed and the cause was traced to a damaged processor pca.Per the technician, the memory card tray was installed forcefully in the wrong direction, resulting in physical damage to the component.Based on the conclusion of the evaluation, it was determined that the cause for the failure was a user related error.Per the technician, the processor pca was damaged due to an incorrectly installed memory card.The processor pca was replaced to resolve the noted damage.There is currently no evidence of a component malfunction associated with this event.Following the repair, the unit was returned to the customer to be placed back into service.There is no indication of a systemic problem.No further investigation or action is warranted.

• 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: elizabeth proctor ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12148156
• MDR Text Key: 260933118
• Report Number: 3030677-2021-12871
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/21/2021
• Initial Date Manufacturer Received: 06/21/2021
• Initial Date FDA Received: 07/10/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2008
• 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