BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 3941811 · Received March 5, 2014

    Report

    Report Number
    1720753-2014-02036
    Event Type
    Malfunction
    Date Received
    March 5, 2014
    Date of Event
    February 13, 2014
    Report Date
    March 5, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE POWER MOTOR RELAY PCB ASSEMBLY WAS EVALUATED AND REPLACED AND THE 5VDC POWER SUPPLY WAS OPTIMIZED TO THE CORRECT OPERATING VOLTAGE. 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 FAILED TO POWER TO A USABLE STATE AND EXHIBITED A NON-RECOVERABLE LOSS OF FUNCTIONALITY. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132973 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1