BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 1014293 · Received March 12, 2008

    Report

    Report Number
    1720753-2008-17936
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 11, 2008
    Manufacturer
    GE OEC MEDICAL SYSTEMS INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO ADDITIONAL INFORMATION AT THIS TIME. WHEN ADDITIONAL INFORMATION IS PROVIDED, IT WILL BE REPORTED AS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 6600 SYSTEM WOULD NOT FLUORO. ANOTHER SYSTEM WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 6600 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK