BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTSTART XL + DEFIBRILLATOR/MONITOR

    MDR report key: 4231776 · Received October 14, 2014

    Report

    Report Number
    1218950-2014-06144
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Report Date
    September 18, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    K110825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO PHILIPS HEALTHCARE THAT THE DEVICE FAILS TESTING BECAUSE IT CANNOT RECOGNIZE PADS AND PT CABLES. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    650001 HEARTSTART XL + DEFIBRILLATOR/MONITOR MKJ PHILIPS MEDICAL SYSTEMS 861290

    Patients

    Seq Age Sex Outcome Treatment
    1