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

Model Number M4735A

Device Problem Inaccurate Synchronization (1609)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/09/2023

Event Type  Injury  

Event Description

It was reported to philips that the device did not synchronize while attempting defibrillation.Additional details have been requested.There was no reported patient death or serious injury, however the reported issue/event impacts or potentially impacts therapy, which could cause or contribute to a death or serious injury if the malfunction were to recur.

Manufacturer Narrative

Philips received a complaint on the heartstart xl defibrillator indicating that the device failed to sync during daily routine.There was reportedly no patient involvement.The customer determined there was a malfunction with the battery and replaced it to resolve the reported issue.The fse evaluated the device on site and confirmed no issues were found following battery replacement.The device remains at the customer site and no further evaluation is warranted at this time.

• 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: daniel derochers ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16691513
• MDR Text Key: 312800666
• Report Number: 3030677-2023-01447
• 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 Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• 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?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: No
• 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