BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1446820 · Received August 24, 2009

    Report

    Report Number
    9680959-2009-00165
    Event Type
    Malfunction
    Date Received
    August 24, 2009
    Date of Event
    June 1, 2009
    Report Date
    June 10, 2009
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT. THE GE SVC REP FOUND THAT THE ARCH CONNECTOR WAS NOT FIXED. THERE WERE POWER SURGES IN THE TUBE. THE GE SVC REP REPLACED THE TUBE. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM DID NOT DISPLAY AN IMAGE AND THERE WERE COLLIMATOR ERRORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7700 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1