BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 1014299 · Received March 12, 2008

    Report

    Report Number
    1720753-2008-17942
    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
    FL, 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 FOOTSWITCH ASSEMBLY OF THE 9800 SYSTEM GAVE THE SURGEON TWO SHOCKS WHEN HE WENT TO USE THE FOOTSWITCH. AFTER SECOND SHOCK THE FOOTSWITCH WORKED AS EXPECTED, AND THE CASE WAS FINISHED. IT WAS NOTED THAT THE FOOTSWITCH WAS NOT IN ANY WATER AND NO VOLTAGE COULD BE FOUND ON THE FOOTSWITCH. THERE WAS NO REPORT OF OPERATOR OR PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS INC. 9800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK