BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEART START XL

    MDR report key: 1945898 · Received December 28, 2010

    Report

    Report Number
    1218950-2010-02743
    Event Type
    Malfunction
    Date Received
    December 28, 2010
    Report Date
    November 12, 2010
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    MKJ
    PMA / PMN Number
    K001725
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE CUSTOMER REPORTED THAT THE DEVICE FAILED TESTING. A LOCAL 3RD PARTY REPAIR SERVICE PROVIDED NEW INFO AND THE SYMPTOM WAS FURTHER EXPLANTED TO BE A FAILURE TO DEFIBRILLATE. THE CUSTOMER REFUSED THE REPAIR ESTIMATE, AND THE DEVICE WAS REMOVED FROM SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE FAILED TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEART START XL MKJ PHILIPS HEALTHCARE M4735A

    Patients

    Seq Age Sex Outcome Treatment
    1