BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2093104 · Received May 3, 2011

    Report

    Report Number
    1720753-2011-06876
    Event Type
    Malfunction
    Date Received
    May 3, 2011
    Date of Event
    April 14, 2011
    Report Date
    May 3, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE FRICTION CLUTCH WAS REPLACED TO RESOLVE THE PROBLEM WITH THE ANTERIOR POSTERIOR TO LATERAL MOVEMENT OF THE SYSTEM. THE EXTENDED FLUOROSCOPY FUNCTION WAS TURNED OFF AT THE CUSTOMER'S REQUEST. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM'S FLUOROSCOPY FUNCTION CONTINUED AFTER THE X-RAY SWITCH WAS RELEASED AND THE LOCK THAT ENABLED THE SYSTEM'S MOVEMENT FROM THE ANTERIOR POSTERIOR VIEW TO THE LATERAL VIEW WOULD NOT MAINTAIN THE LOCKED POSITION. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1