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

Model Number 861290

Device Problem Inadequate User Interface (2958)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported the customer requested replacement of front cover for controls "prob on chassis".Additional details have been requested.There was no patient involvement.

Manufacturer Narrative

This report is based on information provided by philips field service engineer (fse) personnel and has been investigated by the philips complaint handling team.Philips received a complaint regarding the heartstart xl+ indicating a problem with the top cover of the heartstart xl+ controls.The device was not in clinical use at the time when the issue was discovered, and there were no reported patient impacts or injuries.The complaint investigation revealed that the issue with the top cover of the heartstart xl+ controls was not evaluated by a philips employee, resulting in the decision to send an end-of-life (eol) letter to the customer due to the equipment's age and lack of support, ultimately leading to the closure of the case remotely without philips' involvement.Since troubleshooting was not conducted on the device, the reported issue could not be verified, and a cause could not be established.As a result, the reported problem was not confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.To address the reported issue, the resolution involved sending an end of life (eol) letter to the customer and closing the case remotely, given that spare parts for the heartstart xl+ controls were unavailable due to the equipment's age and lack of support.The investigation concludes that no further action is required at this time.

• 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: 18422947
• MDR Text Key: 331665545
• Report Number: 3030677-2023-05129
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: Not provided
• Initial Date FDA Received: 12/31/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: No
• 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