BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3060327 · Received April 11, 2013

    Report

    Report Number
    1720753-2013-04894
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 3, 2013
    Report Date
    April 11, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE HIGH VOLTAGE TANK. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER AND FE REPORTED AN OVERLOAD FAULT ERROR MESSAGE. THIS MESSAGE WILL RESULT IN A SYSTEM SHUT DOWN SITUATION THEREBY NECESSITATING A REBOOT AS INDICATED BY THE CUSTOMER. THERE ARE NO REPORTS OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155360 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1