BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1295523 · Received November 26, 2008

    Report

    Report Number
    9617766-2008-01435
    Event Type
    Malfunction
    Date Received
    November 26, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 24, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE. THE GE SERVICE REP TROUBLESHOOT THE SYSTEM AND FOUND THAT THE MICRO CONTROLLER PCB NODE WOULD DROP OFF SHORTLY AFTER BOOT-UP. HE REPLACED THE COIN BATTERY (WAS LOW) AND ERASED NODES AND DOWNLOADED THE CALIBRATION DATA. ALSO, THE GENERATOR ERROR WAS TRACED TO DEFECTIVE BATTERIES. HE REPLACED BATTERIES AND BATTERY CHARGER PCB. ALSO, HE CHECKED AND TIGHTENED INPUT PWR AND GROUNDING CONNECTIONS TO UNIT WHICH INCLUDED AC PWR PLUG; TB-1 AND ISO. X-FORMER TAP NUTS AS WELL AS CONNECTIONS ON WORKSTATION POWER SUPPLY. THE UNIT FUNCTIONS AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS NO FLUORO. THE SYSTEM DISPLAYED A GENERATOR ERROR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1