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

Model Number 861290

Device Problems Energy Output Problem (1431); Defibrillation/Stimulation Problem (1573)

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

Event Date 03/11/2024

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported to philips that the heartstart xl+ exhibited a therapy issue.There was no reported patient involvement.

Manufacturer Narrative

This report is based on information provided by a philips remote service engineer (rse) and field service engineer (fse) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl+ defibrillator indicating that there was an unspecified therapy issue.The event was outside of use and there was no reported patient nor user harm.Available details indicate that the device had exhibited symptoms of a failure as there was an unspecified therapy issue.Follow-up finding reveals that the issue was the device failed a self-test, specifically the defibrillator test failure, which indicated that the hv (high voltage) capacitor's energy is low.The device was evaluated onsite, operational check was performed and failed.Review of the hw (hardware) error logs revealed low energy level in the capacitor, resulting in the test failure.The customer was provided a quote for services, but the quote was not accepted and the customer has decided to remove the device from service.No repair was performed, no parts replaced.No further investigation is possible.Device remains at the customer site.Based on the information available and the testing conducted, the cause of the reported problem was a component failure.The reported problem was confirmed.The customer was provided a quote for services, but the quote was not accepted and the customer has decided to remove the device from service.The investigation concludes 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: 18987069
• MDR Text Key: 338728247
• Report Number: 3030677-2024-01141
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: HK
• 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 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: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 03/27/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2012
• 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