BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION XR/D

    MDR report key: 1045224 · Received May 13, 2008

    Report

    Report Number
    2126677-2008-00031
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    April 14, 2008
    Report Date
    April 14, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    MQB
    PMA / PMN Number
    K012389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    A GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND DEBRIS LODGED IN THE FOOTPEDAL ASSEMBLY, WHICH PREVENTED THE TABLE LOCKS FROM ENGAGING AND CAUSED THE TABLE TO MOVE IN ALL AXES. THE FE REMOVED THE DEBRIS AND VERIFIED THE FOOTPEDAL AND TABLE LOCK FUNCTIONALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVOLUTION XR/D TABLE TOP WAS MOVING IN ALL AXES WITHOUT RESISTANCE. THERE WAS NEITHER INJURY REPORTED NOR PT INVOLVEMENT. THE CONCERN IS FOR A SERIOUS INJURY IF A PT WERE TO BECOME UNSTEADY AND FALL AS RESULT OF THE FLOAT TABLE.

    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