BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2934557 · Received January 10, 2013

    Report

    Report Number
    1720753-2013-00483
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 21, 2012
    Report Date
    January 10, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND RELUBRICATED THE STEERING BEARINGS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE FE REPORTED THE CRADLE STEERING HANDLE WAS STIFF AND DIFFICULT TO TURN. THERE ARE NO REPORTS OF PT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16055 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1