BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL + DEFIBRILLATOR/MONITOR

    MDR report key: 3812834 · Received April 25, 2014

    Report

    Report Number
    1218950-2014-02338
    Event Type
    Malfunction
    Date Received
    April 25, 2014
    Report Date
    April 4, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    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 THE DEVICE HAD A THERAPY KNOB ERROR. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251178 HEARTSTART XL + DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1