BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6800

    MDR report key: 3962946 · Received June 11, 2014

    Report

    Report Number
    1720753-2014-04956
    Event Type
    Malfunction
    Date Received
    June 11, 2014
    Date of Event
    May 22, 2014
    Report Date
    June 11, 2014
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AND ON SITE INVESTIGATION. THE HAND SWITCH WAS REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED, FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM CONTINUED TO FLUORO WHEN THE SWITCH WAS RELEASED. THIS OCCURRED OUTSIDE OF A PROCEDURE WITH NO PATIENT INVOLVEMENT. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    345507 6800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6800

    Patients

    Seq Age Sex Outcome Treatment
    1