BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APIX TABLE

    MDR report key: 2570856 · Received May 2, 2012

    Report

    Report Number
    1720753-2012-03308
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 17, 2012
    Report Date
    May 4, 2012
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    KXJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REP EVALUATED THE SYSTEM AND REPLACED THE LONGITUDINAL POTENTIOMETER. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM WOULD NOT COMPLETE BOOT UP. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APIX TABLE RADIOLOGIC TABLE KXJ GE OEC MEDICAL SYSTEMS (SLC) APIX TABLE

    Patients

    Seq Age Sex Outcome Treatment
    1