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 08/23/2023

Event Type  malfunction  

Event Description

This report is based on information provided by a philips remote service engineer (rse) and has been reviewed by the philips complaint handling team.Philips received a complaint regarding the heartstart xl+, indicating an error with code hv capacitor low.There was reportedly no patient involvement.The rse determined remotely that the issue was a faulty charging capacitor, and on-site repair was requested by the customer.However, troubleshooting could not be completed for the device due to the equipment's support having ended on 12/31/2022 and no replacement parts being available.This limitation prevents a definitive determination of the exact cause.As a result, the reported problem could not be confirmed.The customer was informed that service wasn't possible due to the device reaching its end of life (eol).Philips concluded the heartstart xl+ monitor/defibrillator, its product lifecycle, with the last shipment in october 2017.The global end of life (eol) is set to conclude on 12/31/2022, initiating the end of support (eos) period.As troubleshooting was not completed for the device, the reported issue could not be verified and a cause could not be established.The reported problem was not 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 is 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 made aware of the end of life terms.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: 17682920
• MDR Text Key: 322637733
• Report Number: 3030677-2023-03502
• 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: 08/23/2023
• Initial Date FDA Received: 09/05/2023
• 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