MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR

Model Number 861290

Device Problems Failure to Deliver Energy (1211); Defibrillation/Stimulation Problem (1573)

Patient Problem Ventricular Fibrillation (2130)

Event Date 01/08/2024

Event Type  Injury  

Event Description

It was reported the patient underwent coronary angiography and experienced sudden ventricular fibrillation.Aed defibrillation was administered, but it was ineffective.Records showed a discharge of 6 joules, and manual defibrillation was immediately performed without any adverse effects on the patient.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.

Event Description

Philips received a complaint on the heartstart xl+ indicating that the aed defibrillation was ineffective.The patient had a sudden ventricular fibrillation during coronary angiography, aed electrical defibrillation was given, which was ineffective, and the recordings showed a discharge of 6 joules.Patient was immediately defibrillated manually, defibrillation was delayed more than 30 seconds, however, there was no patient harm or injury reported to philips.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 authorized service provider (asp) and has been investigated by the philips complaint handling team.The device was evaluated by customer only.Customer did the operational check and tested the discharge level.However, the reported problem cannot be reproduced.Patient event files and device data logs were requested to further investigation.However, customer did not provide the required files, technical investigation and clinical harm review is not applicable.Based on the information available and the testing conducted, the cause of the reported problem was unable to confirmed.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.H3 other text : the device was evaluated by customer only.

• Brand Name: HEARTSTART XL+ DEFIBRILLATOR/MONITOR
• 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: 18509707
• MDR Text Key: 332878480
• Report Number: 3030677-2024-00179
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: 00884838023680
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K110825
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2024
• Initial Date FDA Received: 01/14/2024
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 02/04/2024
• 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
• Patient Age: 39 YR
• Patient Sex: Male