BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 4820875 · Received June 3, 2015

    Report

    Report Number
    1720753-2015-02329
    Event Type
    Malfunction
    Date Received
    June 3, 2015
    Date of Event
    April 28, 2015
    Report Date
    June 3, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE, HIGH VOLTAGE CABLE, BATTERY PACK, AND X-RAY TUBE WERE 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 THAT THE SYSTEM WOULD INTERMITTENTLY NOT BOOT UP. THERE WAS NO PT INJURY OR DEATH REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357846 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9900 E2-2656

    Patients

    Seq Age Sex Outcome Treatment
    1