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

Model Number M4735A

Device Problem Failure to Deliver Shock/Stimulation (1133)

Patient Problems Arrhythmia (1721); Unspecified Heart Problem (4454)

Event Date 04/27/2023

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 the pacing feature on defibrillator did not work during a code.Although no direct adverse event to the patient or user was reported, we are considering this to be a serious injury due to a serious deterioration in the state of health of the patient because life-saving therapy/treatment may have been interrupted/delayed.

Manufacturer Narrative

This report is based on information provided by philips field service personnel and has been investigated by the philips complaint handling team.The following functional tests were performed: the engineer performed the preventative maintenance (pm) steps using the pm checklist and also used the defib tested and safety meter.Results of functional testing indicated that there was no problem found with the device and the device was operating normally.It was stated the defibrillator failure did not cause or contribute to the patient issue, but the staff did have a problem during treatment.The device was not placed back into service as it is not needed; it is being kept as a training unit.Based on the information available and the testing conducted we were unable to replicate the reported problem.The reported problem was not confirmed.The device was confirmed to be operating per specifications and no failure was identified.The investigation concludes that no further action is required at this time.

Event Description

It was reported the pacing feature on defibrillator did not work during a code.Multiple attempts were made to obtain additional clinical and patient information regarding the complaint in order to determine if an adverse event occurred.However, these attempts were unsuccessful.Although harm cannot be confirmed, the delay in treatment caused by the reported device event will be considered a failure to shock event and adverse event because live-saving therapy/treatment has been interrupted and or delayed and likely led to a deterioration in the state of the health of 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: laura scanlan ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16899498
• MDR Text Key: 314885347
• Report Number: 3030677-2023-01936
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021453
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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?: 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
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/25/2023
• 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