BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 11975740 · Received June 10, 2021

    Report

    Report Number
    3030677-2021-12100
    Event Type
    Injury
    Date Received
    June 10, 2021
    Date of Event
    May 13, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838023680
    PMA / PMN Number
    K110825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : THE CUSTOMER EVALUATED THE DEVICE WITH NO FAULT FOUND.

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THE DEVICE WAS USED TO SHOCK AND LOST OUTPUT DURING PATIENT USE. THE CUSTOMER WAS UNABLE TO PROVIDE ADDITIONAL DETAILS REGARDING THE PATIENT OR PROCEDURE. WE ARE CONSIDERING THIS TO BE AN ISSUE POSSIBLY CAUSING A DELAY IN LIFE SAVING THERAPY AND THIS WILL BE CONSIDERED A SERIOUS INJURY. THE PATIENT OUTCOME IS NOT KNOWN. THERE WERE NO ECG STRIPS OR PATIENT EVENT FILES AVAILABLE FOR REVIEW. THE CUSTOMER EVALUATED THE DEVICE WITH NO FAULT FOUND. NO ADDITIONAL DETAILS ARE AVAILABLE. PHILIPS DID NOT EVALUATE THE DEVICE. THE DEVICE REMAINS WITH THE CUSTOMER. NO PARTS WERE REPLACED. PHILIPS WAS NOT ABLE TO CONFIRM THE REPORTED MALFUNCTION. BECAUSE THE PROBLEM COULD NOT BE RECREATED, THE CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THE DEVICE WAS USED TO SHOCK AND LOST OUTPUT. THE CUSTOMER HAS LIMITED INFORMATION AND IS STILL INVESTIGATING; AT PRESENT, THEY DO NOT KNOW IF THIS WAS A TECHNICAL OR CLINICAL USER ISSUE. ADDITIONAL DETAILS HAVE BEEN REQUESTED. WE ARE CONSIDERING THIS TO BE AN ISSUE POSSIBLY CAUSING A DELAY IN LIFE SAVING THERAPY AND THIS WILL BE CONSIDERED A SERIOUS INJURY. HOWEVER, NO DIRECT ADVERSE EVENT TO THE PATIENT OR USER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    870509 HEARTSTART XL+ DEFIBRILLATOR/MONITOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC 861290 00884838023680

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention