BEUDAMED
    FDA Adverse Event Other Summary report: N

    MULTISCAN TABLE MODEL 8083

    MDR report key: 1977266 · Received January 28, 2011

    Report

    Report Number
    1932056-2011-00001
    Event Type
    Other
    Date Received
    January 28, 2011
    Date of Event
    November 9, 2009
    Report Date
    January 25, 2011
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INCIDENT RESULTED FROM WELD FAILURE. WHILE LESS THAN 0.02% WELDS HAVE FAILED, THE INCIDENCE OF FAILURE IN 2004 IS HIGHER THAN IN OTHER YEARS. FOR THAT REASON, ALL CUSTOMERS WITH MODELS WHO HAVE REPORTED WELD FAILURE, AND ARE FROM BATCHES OF STEEL USED IN 2004, HAVE BEEN CONTACTED AND AN UPGRADE WAS INSTALLED TO ENSURE NO FAILURES IN THE FUTURE.

    Description of Event or Problem · 1

    WITH THE PT ON THE TABLE IN THE FOWLER POSITION (SITTING UP WITH BACK BEING SUPPORTED BY THE UPPER PORTION OF THE TABLE), THE LOWER FOWLER ACTUATOR MOUNT TAB BROKE AWAY FROM THE TABLE CAUSING THE HEAD OF THE TABLE TO FALL TO THE FLOOR. THE PT WAS ABLE TO AVOID INJURY BY UTILIZING THE SAFETY MECHANISMS BUILT INTO THE TABLE. SPECIFICALLY, THE PT GRABBED ONTO THE SAFETY RAIL BEFORE HE FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTISCAN TABLE MODEL 8083 GENERAL ULTRASOUND TABLE LGX MEDICAL POSITIONING, INC. 8083

    Patients

    Seq Age Sex Outcome Treatment
    1 Other