BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA ZPER FD20

    MDR report key: 3922489 · Received June 2, 2014

    Report

    Report Number
    3003768277-2014-00059
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Report Date
    May 20, 2014
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K031333
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WHEN INVESTIGATION IS COMPLETED A F/U REPORT WILL BE SENT TO THE FDA.

    Description of Event or Problem · 1

    PHILIPS RECEIVED A COMPLAINT FROM MANUFACTURING FROM THE IXR BEST MANUFACTURING PLANT, THAT AS RESULT OF A FAULTY AUTOMATIC MOTOR CONTROLLER, A PROBLEM IN ERROR HANDLING DURING STARTUP OF THE SYSTEM (POST OF POSITIONING SOFTWARE) WAS DETECTED WHICH CAN RESULT IN A HAZARDOUS MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321816 ALLURA ZPER FD20 IZI PHILIPS HEALTHCARE 722028 NOT RELEVANT

    Patients

    Seq Age Sex Outcome Treatment
    1