BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2943193 · Received January 21, 2013

    Report

    Report Number
    1720753-2013-00860
    Event Type
    Malfunction
    Date Received
    January 21, 2013
    Date of Event
    January 4, 2013
    Report Date
    January 21, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED AN OVERLOAD FAULT, WHICH COULD CAUSE THE SYSTEM TO SHUT DOWN ON ITS OWN. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28803 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1