BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FR3

    MDR report key: 3952740 · Received May 19, 2014

    Report

    Report Number
    3030677-2014-01252
    Event Type
    Malfunction
    Date Received
    May 19, 2014
    Report Date
    May 12, 2014
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MKJ
    PMA / PMN Number
    111693
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT EVALUATION PENDING DEVICE RETURN.

    Description of Event or Problem · 1

    THE USER IS ALLEGING THE DEVICE POWERED OFF DURING DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296304 FR3 MKJ PHILIPS MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1