BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION XR/D

    MDR report key: 1361498 · Received March 5, 2009

    Report

    Report Number
    2126677-2009-00014
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    February 5, 2009
    Report Date
    February 5, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    MQB
    PMA / PMN Number
    K012389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE FIELD ENGINEER (FE) INSPECTED THE SYSTEM AND FOUND DEBRIS IN THE PEDAL ASSEMBLY THAT CAUSED THE FLOAT CONDITION. THE FE REMOVED THE DEBRIS AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING AS EXPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS WERE NOT ACTUATING, CAUSING THE TABLETOP TO UNEXPECTEDLY MORE IN BOTH LONGITUDINAL AND LATERAL DIRECTIONS WITHOUT RESISTANCE (FREE FLOAT). THE ISSUE WAS DISCOVERED DURING SET-UP. THERE WAS NO INJURY REPORTED. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PT OR OPERATOR WERE UNAWARE OF THIS CONDITION WHILE LOADING OR UNLOADING A PT. THE ENSUING INSTABILITY COULD LEAD TO A FALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVOLUTION XR/D MQB/KPR MQB GE MEDICAL SYSTEMS, LLC 2259988-2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA