MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR; DEFIBRILATOR

Model Number 861290

Device Problem Failure to Discharge (1169)

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

Event Date 05/05/2022

Event Type  malfunction  

Event Description

It was reported to philips that the device experienced ecg cannot detect discharge issue.There was no report of patient involvement.The customer requested that an authorized field service engineer (fse) be dispatched to the customer site to evaluate the noted issue.Upon evaluation of the device, the reported issue was confirmed and the cause was traced to a faulty capacitor and processor pca.Based on the conclusion of the evaluation, it was determined that this was a malfunction of the capacitor and processor pca.Multiple parts were replaced to resolve the noted issue.The device passed all performance assurance tests and was placed back into use with the customer.The device remains at the customer site.There is no indication of a systemic problem.No further investigation or action is warranted.We are unable to determine the root cause of the event as multiple parts were required for replacement.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• Type of Device: DEFIBRILATOR
• 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: jazmin del rosa ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 14402789
• MDR Text Key: 291705086
• Report Number: 3030677-2022-02555
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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