BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 12079378 · Received June 28, 2021

    Report

    Report Number
    3030677-2021-12536
    Event Type
    Malfunction
    Date Received
    June 28, 2021
    Date of Event
    June 2, 2021
    Manufacturer
    PHILIPS NORTH AMERICA LLC
    Product Code
    MKJ
    UDI-DI
    00884838023680
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILS THE THERAPY TEST. THE CUSTOMER WORKED WITH THE TECHNICAL SUPPORT REPRESENTATIVE. THE THERAPY TEST FAILURE IS RELATED TO MALFUNCTION OF HIGH VOLTAGE CAPACITOR. THE DEVIE NEEDS A HIGH VOLTAGE CAPACITOR. UPON CONCLUSION OF THE EVALUATION, IT WAS DETERMINED THAT THIS WAS A MALFUNCTION OF THE HIGH VOLTAGE CAPACITOR, THE REPLACEMENT FOR WHICH WAS ORDERED TO CUSTOMER. THE CUSTOMER TO INSTALL CAPACITOR. THE DEVICE REMAINS AT THE CUSTOMER SITE AND NO FURTHER EVALUATION IS WARRANTED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE FAILS THE THERAPY TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    975135 HEARTSTART XL+ DEFIBRILLATOR/MONITOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC 861290 00884838023680

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown