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

Model Number M3535A

Device Problem Data Problem (3196)

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

Event Date 03/31/2021

Event Type  malfunction  

Event Description

While performing bench service for the device, it was identified by an authorized bench technician that they were unable to obtain the current software / available options installed on the unit.

Event Description

While performing bench service for the device, it was identified by an authorized bench technician that they were unable to obtain the current software / options installed on the unit.The customer requested that the device be returned for bench repair.The device was received by the bench repair service on 24-mar-2021.Upon evaluation of the device by an authorized bench technician, it was discovered that the current options and software installed on the device were not readable.As a result of the noted failure, it was advised that the processor pca would need to be replaced to return the device to working condition.The processor pca was returned to the failure analysis lab for evaluation.The component was visually inspected for any mechanical damage and/or contamination, and no anomalies were found.Once installed in an mrx test fixture, it was verified that the processor pca was faulty as the unit would reboot with any keypress.This issue was typically tied to a corrupt flash memory but attempts to re-flash the component failed twice.Upon conclusion of the evaluation, the processor pca was verified to be faulty.The evaluation data was recorded and the component was scheduled to be archived.Based on the conclusion of the evaluation, it was determined that this was a malfunction of the processor pca.The processor pca was replaced to resolve the noted issue.Following the repair, calibrations were completed for preventative maintenance and 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: daniel derochers ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 11697545
• MDR Text Key: 246430252
• Report Number: 3030677-2021-11141
• 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?: Yes
• Date Returned to Manufacturer: 03/24/2021
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/31/2021
• Initial Date Manufacturer Received: 03/31/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/09/2012
• 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