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

Model Number M4735A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/09/2024

Event Type  Injury  

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 that the service failed to shock the patient.

Event Description

This report is based on information provided by philips remote service lead personnel and has been investigated by the philips complaint handling team.Philips received a complaint about the heartstart xl indicating that it failed to deliver a shock.The report stated that the device was in use at the time of the event, and there was reportedly patient harm.The clinical reassessment was performed by the philips pms clinical expert based on information currently available in the record indicating that the failure to deliver a shock was likely due to the absence of a data card in the device and suboptimal pressing of the shock button.Despite diligent inquiries into the patient's condition, treatment outcomes, procedural attempts, and the management of the reported event, specific details remain unknown.Furthermore, multiple attempts were made to gather information regarding the cause and resolution of the reported problem, yet all queries were met with a singular response: 'asku,' without any additional clarification provided.Based on the available information and testing conducted, the possible cause of the reported issue was the absence of a data card in the device and suboptimal pressing of the shock button; however, despite making multiple attempts to request information about the cause and resolution of the reported problem, the only response received for all asked questions was 'asku,' with no additional information provided.Therefore, the exact cause of the reported problem could not be definitively confirmed.We are unable to confirm the cause and final disposition of the device because the only response received for all asked questions was 'asku,' with no additional information provided.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

Updated summary and code grids.

• 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: 18650996
• MDR Text Key: 334659201
• Report Number: 3030677-2024-00474
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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?: No
• 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: 01/09/2024
• Initial Date FDA Received: 02/06/2024
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 02/07/2024
• 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