BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7700

    MDR report key: 1241681 · Received November 19, 2008

    Report

    Report Number
    9680959-2008-00221
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 28, 2008
    Report Date
    November 17, 2008
    Manufacturer
    GE OEC MEDICAL SSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE GE SERVICE REP REPLACED THE INTERCONNECT CABLE AND TESTED THE SYSTEM BY REBOOTING AND TAKING FLUORO SHOTS. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE CABLE THAT CONNECTS THE MONITOR CART TO THE C-ARM SHUTS DOWN IF THE CABLE IS MOVED AROUND BY THE USER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1