BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GE OEC FLUOROSTAR/7800

    MDR report key: 2760147 · Received August 13, 2007

    Report

    Report Number
    9680959-2007-00065
    Event Type
    Malfunction
    Date Received
    August 13, 2007
    Date of Event
    July 19, 2007
    Report Date
    August 13, 2007
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION BY A GE REPRESENTATIVE HAS NOT BEEN COMPLETED AT THIS TIME. PARTS HAVE BEEN ORDERED, BUT NOT RECEIVED AND INSTALLED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM WOULD INTERMITTENTLY SHUT DOWN ON ITS OWN. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GE OEC FLUOROSTAR/7800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 7800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1