BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 11663901 · Received April 14, 2021

    Report

    Report Number
    3030677-2021-10970
    Event Type
    Malfunction
    Date Received
    April 14, 2021
    Date of Event
    March 25, 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
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS THAT THE DEVICE EXPERIENCED A DEFIB TEST FAILURE DUE TO A LOW CAPACITOR OUTPUT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    561010 HEARTSTART XL+ DEFIBRILLATOR/MONITOR DEFIBRILLATOR MKJ PHILIPS NORTH AMERICA LLC 861290 00884838023680

    Patients

    Seq Age Sex Outcome Treatment
    1