MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEART START XL; DEFIBRILLATOR

Model Number M4735A

Device Problems Mechanical Problem (1384); Inadequate User Interface (2958)

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

Event Date 01/24/2024

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 defibrillator/monitor exhibited a button failure.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 a button failure.The event was outside of use and there was no reported patient nor user harm.Available details indicate that the device had experienced a button failure.It was determined onsite evaluation was needed to further assess the issue.The device was evaluated onsite.There were no chirps emitted nor error messages issued.The fse performed the self-test and reviewed the hw (hardware) error logs, it was determined a function button on the device is not working.The device was restarted, resolving the issue.There were no parts replaced and no settings were changed.The device is returned to full functionality, returned to service and remains at the customer site.Based on the information available, the cause of the reported problem was an apparent component failure.The root cause of the reported problem could not be confirmed because the device was not returned for additional investigation.The reported problem was confirmed.The device was operational after the device was restarted.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.

Manufacturer Narrative

This report is based on information provided by a philips remote service engineer (rse) and philips authorized service provider (asp) and has been investigated by the philips complaint handling team.Philips received a complaint on the heartstart xl defibrillator indicating a button failure.The event was outside of use and there was no reported patient nor user harm.Available details indicate that the device had experienced a button failure.It was determined onsite evaluation was needed to further assess the issue.The device was evaluated onsite.There were no chirps emitted nor error messages issued.The asp performed the self-test and reviewed the hw (hardware) error logs, it was determined a function button on the device is not working.The device was restarted, resolving the issue.There were no parts replaced and no settings were changed.The device is returned to full functionality, returned to service and remains at the customer site.Based on the information available, the cause of the reported problem was an apparent component failure.The root cause of the reported problem could not be confirmed because the device was not returned for additional investigation.The reported problem was confirmed.The device was operational after the device was restarted.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: HEART START XL
• 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: 18702046
• MDR Text Key: 335349091
• Report Number: 3030677-2024-00590
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K021453
• 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,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: M4735A
• Device Catalogue Number: M4735A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/14/2024
• Supplement Dates Manufacturer Received: 01/24/2024; Not provided
• Supplement Dates FDA Received: 04/18/2024; 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2012
• 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