BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION XR/D

    MDR report key: 1140568 · Received August 28, 2008

    Report

    Report Number
    2126677-2008-00062
    Event Type
    Malfunction
    Date Received
    August 28, 2008
    Date of Event
    March 4, 2008
    Report Date
    March 4, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    MQB
    PMA / PMN Number
    K012389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND AN ISSUE WITH THE CABLE COVER WHICH ENABLED ACTIVATION OF THE FOOT PEDAL AND PREVENTED THE TABLE LOCKS FROM ENGAGING. THE FE FIXED THE COVER TO THE FLOOR AND VERIFIED THAT THE TABLE LOCKS WERE PERFORMING ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TABLE LOCKS DID NOT ACTUATE, CAUSING THE TABLETOP TO MOVE IN TWO DIRECTIONS WITHOUT RESISTANCE. THERE WAS NO PATIENT INVOLVEMENT NOR INJURY REPORTED. THE SITE DISCOVERED THE ISSUE DURING ITS QAP TESTING. THIS SITUATION COULD CONTRIBUTE TO AN INJURY IF A PATIENT OR OPERATOR WERE UNAWARE OF THIS CONDITION, WHILE LOADING A PATIENT. 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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA