BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVOLUTION XR/D-2X

    MDR report key: 1002768 · Received February 26, 2008

    Report

    Report Number
    2126677-2008-00018
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 29, 2008
    Report Date
    January 29, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC.
    Product Code
    MQB
    PMA / PMN Number
    K012389
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER ADJUSTED THE TABLE LOCKS AND VERIFIED THE LOCKS FUNCTIONALITY. THE PRODUCT WAS RETURNED TO SERVICE. PERIODIC PREVENTATIVE MAINTENANCE IS CURRENTLY IN PLACE PER THE SYSTEM'S PLANNED MAINTENANCE PROCEDURE THAT INCLUDES INSTRUCTIONS TO INSPECT AND PERFORM FUNCTIONALITY CHECK ON TABLE LOCKS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVOLUTION XR/D TABLE LOCKS WERE SLIPPING. 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 A RESULT OF THE SLIPPING TABLE LOCKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA