BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRESTILIX 1600X

    MDR report key: 558912 · Received May 7, 2004

    Report

    Report Number
    9611343-2004-00013
    Event Type
    Malfunction
    Date Received
    May 7, 2004
    Date of Event
    April 6, 2004
    Report Date
    May 7, 2004
    Manufacturer
    GE MEDICAL SYSTEMS EUROPE
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    WHEN CUSTOMER TILTED THE TABLE TO THE VERTICAL POSITION THE SFD (SPOT FILM DEVICE) SLID TO THE FOOT POSITION UNTIL THE MECHNICAL END WAS REACHED, BREAKING THE COVERS OF SFD AND THE POTENTIOMETER OF THE CASSETTE TRAY. CONCERN IS FOR POSSIBLE PT INJURY. THERE WERE NO INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRESTILIX 1600X DIAGNOSTIC X-RAY JAA GE MEDICAL SYSTEMS EUROPE 829106G035 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN