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

Model Number 861290

Device Problem Device Alarm System (1012)

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

This report is based on information provided by a philips remote service engineer and has been investigated by the philips complaint handling team.Philips received a complaint on the 861290 (heartstart xl+ defibrillator/monitor) indicating that the device was chirping and emitting an error message of power failure.The event was outside of use and there was no reported patient nor user harm.Available details indicate that the device was chirping and emitting an error message of power failure in the stand-by mode.Functional tests were performed, the device failed delivering the defibrillation therapy.Device information report (device logs) was reviewed, it was determined the hv (high voltage) therapy capacitor and the processor pca (printed circuit board) are faulty.It was recommended to replace to the components to resolve the issue.It is confirmed the xl+ device is out of support and has reached it's end-of-life status.Replacement device and replacement components are no longer available.No repairs performed.Device remains at the customer site.Based on the information available and the testing conducted, the cause of the reported problem was faulty hv (high voltage) therapy capacitor and the processor pca (printed circuit board).The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.A review of the risk management file was performed and the potential severity of s3 has been identified in the risk document.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.The customer was informed the device has reached it's end of life/end of support status.End of life letter emailed to the customer.The replacement device and replacement components are no longer available.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 17610568
• MDR Text Key: 321812167
• Report Number: 3030677-2023-03333
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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

• 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
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 08/24/2023
• 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