BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLEN MEDICAL SYSTEMS

    MDR report key: 1638229 · Received March 18, 2010

    Report

    Report Number
    MW5015232
    Event Type
    Malfunction
    Date Received
    March 18, 2010
    Date of Event
    March 15, 2010
    Report Date
    March 18, 2010
    Manufacturer
    ALLEN MEDICAL SYSTEMS
    Product Code
    BTX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN A LEFT LATERAL POSITION FOR A PROCEDURE, WITH THE LEFT ARM SECURED TO THE ARMBOARD. AT SOME UNDETERMINED POINT IN THE PROCEDURE, THE ARMBOARD BECAME DETACHED FROM THE TABLE. THIS WAS NOTED AT THE END OF THE PROCEDURE WHILE THE DRAPES WERE BEING REMOVED. THE ARMBOARD WAS STILL ATTACHED TO THE PATIENT'S ARM BY THE SOFT SAFETY STRAP. THE SAFETY STRAP CAUSED THE ARMBOARD TO REMAIN ATTACHED AND PULL THE ARM IN A DOWNWARD DIRECTION, HYPER EXTENDING THE ELBOW. NO BRUISING NOTED, SLIGHT AMOUNT OF REDNESS NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALLEN MEDICAL SYSTEMS PATIENT POSITIONING ARM BOARD BTX ALLEN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other