BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RTI/RTP/RTE

    MDR report key: 1162223 · Received September 16, 2008

    Report

    Report Number
    2126677-2008-00067
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 18, 2008
    Report Date
    August 18, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    K813173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE FIELD ENGINEER (FE) WAS DISPATCHED TO THE SITE AND FOUND A BENT COVER WHICH PRESSED ON THE RIGHT FOOT SWITCH, PREVENTING THE TABLE LOCKS FROM ENGAGING. THE FE FIXED THE COVER AND VERIFIED THAT THE TABLE LOCKS WERE FUNCTIONING 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 INJURY REPORTED. 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 RTI/RTP/RTE KPR GE MEDICAL SYSTEMS, LLC 46-216697P3

    Patients

    Seq Age Sex Outcome Treatment
    1