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

Model Number M3535A

Device Problem Device Remains Activated (1525)

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

Event Date 02/19/2021

Event Type  malfunction  

Event Description

It was reported to philips that the device won't turn off.The alleged failure was observed while the device was in use on a patient, however, no adverse patient impact was reported by the customer.

Event Description

It was reported to philips that the device won't turn off.The alleged failure was observed while the device was in use on a patient, however, no adverse patient impact was reported by the customer.

Event Description

It was reported to philips that the device won't turn off.The alleged failure was observed while the device was in use on a patient, however, no adverse patient impact was reported by the customer.The device was received by bench repair.An evaluation was performed by an authorized bench technician and the reported issue was confirmed and traced to a faulty processor pca.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, functional testing was successfully completed with no noted issues that could have caused or contributed to the alleged failure.Upon conclusion of the evaluation, the processor pca was found to be fully functional and the reported issue could not be verified or duplicated.The evaluation data was recorded and the component was scheduled to be scrapped.Upon conclusion of the initial evaluation, it was originally reported that this was a malfunction of the processor pca.The processor pca was replaced to resolve the reported issue and the device was returned to the customer site.However, a follow up analysis of the returned processor pca was completed and there were no noted issues that could have caused or contributed to a potential malfunction.The processor pca was found to be fully functional and a cause for the original failure could not be determined.No further investigation or action is warranted at this time.No further evaluation is required at this time.

• Brand Name: HEARTSTART MRX
• 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: 11505792
• MDR Text Key: 240438562
• Report Number: 3030677-2021-10266
• 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,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2022
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/19/2021
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2007
• 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