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

Model Number M4735A

Device Problem Failure to Discharge (1169)

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

Event Date 03/05/2024

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 intermittently does not discharge.There was no reported patient involvement.

Manufacturer Narrative

This report is based on information provided by a philips remote service engineer (rse) and an authorized service provider (asp) engineer and has been investigated by the philips complaint handling team.Philips received a complaint on the efficia dfm100 defibrillator/monitor indicating that the device cannot discharge.The event was outside of use and there was no reported patient nor user harm.The device was evaluated onsite and an operational check was performed confirming the issue.It was determined that the power pca (printed circuit board) was faulty.The power pca was repaired resolving the issue.There were no parts replaced.The device was returned to full functionality and returned to service.Based on the information available and the testing conducted, the cause of the reported problem was a component failure.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The device was operational after repairs were completed.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: 18934058
• MDR Text Key: 338032595
• Report Number: 3030677-2024-01028
• 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

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: 03/05/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2009
• 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