BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3142738 · Received May 24, 2013

    Report

    Report Number
    1720753-2013-06414
    Event Type
    Malfunction
    Date Received
    May 24, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 24, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FSE FOUND THE BATTERY WAS SHORTED OUT AND HAD ZERO VOLTS UNDER LOAD. IT IS A REASONABLE EXPECTATION THAT THE SYSTEM WAS NOT ABLE TO PROVIDE ENOUGH POWER TO CREATE EXCESSIVE RADIATION. THE BATTERY WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A FILAMENT REGULATOR ERROR THEN A PRECHARGE VOLTAGE ERROR AND WAS UNABLE TO MAKE X-RAY EXPOSURES. THE PRECHARGE VOLTAGE ERROR WILL LIKELY PREVENT THE SYSTEM FROM BOOTING. THERE WAS NO PATIENT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231321 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1