BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 1241684 · Received November 19, 2008

    Report

    Report Number
    9617766-2008-01430
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 23, 2008
    Report Date
    November 19, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER. THE GE SERVICE REP FOUND A KEY SWITCH THAT HAD BEEN TURNED BETWEEN THE ON AND OFF POSITION. THE UNIT WAS ABLE TO MAKE X-RAYS BUT COULD NOT GO UP OR DOWN. THERE WAS NO ERROR CODE. HE PUT KEY SWITCH TO THE ON POSITION. HE REPLACED THE POWER SUPPLY. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER WENT TO MOVE THE C-ARM AND IT WOULD NOT MOVE UP OR DOWN. SHE WAS ABLE TO COMPLETE THE CASE BY MOVING THE TABLE INSTEAD.

    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