BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7900

    MDR report key: 1232593 · Received November 13, 2008

    Report

    Report Number
    9680959-2008-00216
    Event Type
    Malfunction
    Date Received
    November 13, 2008
    Date of Event
    October 17, 2008
    Report Date
    November 13, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER.

    Description of Event or Problem · 1

    THERE WAS A MANUFACTURING DEFECT ON THE RIBBON CABLE SOCKET TO THE COLLIMATOR PLUG. THE INTERFACE BOARD WAS REPLACED ON THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 7900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1