BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPAX 40E

    MDR report key: 864970 · Received June 14, 2007

    Report

    Report Number
    2126677-2007-00017
    Event Type
    Injury
    Date Received
    June 14, 2007
    Date of Event
    June 2, 2007
    Report Date
    June 6, 2007
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    IZZ
    PMA / PMN Number
    K884930
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE FIELD ENGINEER THAT WAS DISPATCHED TO THE SITE NOTICED THAT THE VINYL COVER ON THE FOOT PEDAL FOR THE TABLE WAS LOOSE. IT WAS SURMIZED THAT THIS VINYL COVER JAMMED THE FOOT PEDAL IN THE "RELEASE" POSITION NOT ALLOWING THE TABLE LOCKS TO ENGAGE. THE FIELD ENGINEER RE-GLUED THE VINYL COVER TO THE FOOT PEDAL AT THE SITE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS THE PATIENT WAS BEING PLACED ONTO THE TABLE TOP, THE TABLE TOP MOVED STARTLING THE PATIENT WHICH LEAD TO THE PATIENT FALLING TO THE FLOOR. INITIAL REPORT WAS THAT THE PATIENT HAD RECEIVED A BROKEN KNEE FROM THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPAX 40E IZZ GE MEDICAL SYSTEMS, LLC 2208203 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention