BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7600

    MDR report key: 1241679 · Received November 19, 2008

    Report

    Report Number
    9680959-2008-00219
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 17, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT. THE SYSTEM WAS REPAIRED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM WAS SWITCHING MODES. THE FLUORO SWITCH GOES BACK AND FORTH BETWEEN LIVE AND DIGITAL WHEN THE SWITCH IS PRESSED AND ALSO MAKES THE COLLIMATOR ACT STRANGELY. ALSO THE FRONT WHEEL ON THE C-ARM WAS JAMMED. NO PT WAS INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1