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

Model Number M4735A

Device Problems Failure to Deliver Shock/Stimulation (1133); Energy Output Problem (1431)

Patient Problems Atrial Fibrillation (1729); Insufficient Information (4580)

Event Date 02/09/2024

Event Type  Injury  

Event Description

It was reported that during a cardioversion the defibrillator discharged at the 3rd attempt.

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.

Manufacturer Narrative

The device is evaluated at customer site by fse.Based on the results of the analysis, it was determined that the product has malfunctioned and the cause of the reported problem was defective condenser, power pca (printed circuit assembly) and control pca.However, device is eol (end of life) and no repair work performed by philips.Based on the information available and results of additional analysis, no further action is necessary at this time.

Event Description

Philips received a complaint on the heartstart xl defibrillator indicating that device did not discharge.There was patient involvement and no information available regarding the impact to the patient.

• 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: 18864539
• MDR Text Key: 337187114
• Report Number: 3030677-2024-00869
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• 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?: Yes
• 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?: No
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/08/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/13/2024
• 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
• Patient Outcome(s): Life Threatening