BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASSCAN TABLE MODEL 2184

    MDR report key: 1007971 · Received February 27, 2008

    Report

    Report Number
    1932056-2008-00001
    Event Type
    Other
    Date Received
    February 27, 2008
    Date of Event
    December 11, 2006
    Report Date
    February 13, 2008
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 THE SAME MODEL THAT WAS MANUFACTURED FROM THE SAME BATCH OF STEEL IN 2004 WILL BE CONTACTED AND AN UPGRADE WILL BE INSTALLED TO ENSURE NO FAILURES IN THE FUTURE.

    Description of Event or Problem · 1

    AS THE PT LAID ON THE VASCAN TABLE DURING AN EXAM, THE UPPER TRENDELENBURG ACTUATOR MOUNT BRACKET BROKE AWAY FROM THE FRAME. THIS CAUSED THE HEAD END OF THE TABLE TO FALL RAPIDLY TO THE FLOOR. THE PT FELL OFF THE TABLE AND LANDED ON THE FLOOR. PT COMPLAINED OF NECK PAIN. NO SUBSEQUENT INJURY HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASSCAN TABLE MODEL 2184 GENERAL VASCULAR ULTRASOUND TABLE LGX MEDICAL POSITIONING, INC. 2184

    Patients

    Seq Age Sex Outcome Treatment
    1 Other