BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL+ DEFIBRILLATOR/MONITOR

    MDR report key: 3222098 · Received July 2, 2013

    Report

    Report Number
    1218950-2013-02797
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    June 17, 2013
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT AFTER TWO SUCCESSFUL SHOCKS THEY WERE UNABLE TO DELIVER A THIRD SHOCK WITH THIS DEVICE. THEY SWITCHED TO A DIFFERENT DEFIBRILLATOR AND USING THE SAME DEFIB PADS WERE ABLE TO DELIVER THERAPY. THERE WAS NO NEGATIVE PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300333 HEARTSTART XL+ DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1