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

Model Number 861290

Device Problems Circuit Failure (1089); Electrical /Electronic Property Problem (1198)

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

Event Date 12/26/2023

Event Type  malfunction  

Event Description

It was reported to philips that the device has a processor pca issue.There was no patient involvement.

Manufacturer Narrative

The fse checked the log and confirmed that the processor pca failed.However, the customer was informed that service could no longer be completed on the unit as the device had reached end of life (eol).Philips has made the decision to discontinue the heartstart xl+ monitor/defibrillator, which has reached the end of its product life cycle.The last date of shipment for the heartstart xl+ was (b)(6) 2017.The end of life (eol) is scheduled globally to end (b)(6) 2022, where the end of support (eos) period will then begin.Based on the information available and the testing conducted, the cause of the reported problem was a malfunction of the processor pca.The reported problem was confirmed.The fse informed the customer that parts are no longer available for ordering.The customer was made aware of the end of life terms and the device remains at the customer site.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: 18503407
• MDR Text Key: 332783883
• Report Number: 3030677-2024-00172
• 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
• 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?: No
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 03/26/2024
• Supplement Dates FDA Received: 03/27/2024
• 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