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

Model Number 861290

Device Problems Device Alarm System (1012); Insufficient Information (3190)

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

Event Date 08/02/2023

Event Type  malfunction  

Event Description

It was reported that was an error report.No patient involvement reported at this time.

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

This report is based on information provided by a philips remote service engineer (rse) and has been investigated by the philips complaint handling team.Philips received a complaint on the 861290 (heartstart xl+ defibrillator/monitor) indicating that there was an error report.The event was outside of use and there was no reported patient nor user harm.Remote support was provided, the device was experiencing an error report as the device failed the operational check, specifically the therapy delivery test.The customer declined repair and service.No parts replaced.Device remains at the customer site.Based on the information available and the testing conducted we were unable to replicate the reported problem.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 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 has declined any further service or repairs.It has been concluded that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

Updated summary and grids.

• 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: 17640864
• MDR Text Key: 322148994
• Report Number: 3030677-2023-03398
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/02/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 08/02/2023
• Supplement Dates FDA Received: 09/15/2023
• 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