BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASSCAN MODEL 2284

    MDR report key: 1032484 · Received February 12, 2008

    Report

    Report Number
    1932056-2007-00004
    Event Type
    Other
    Date Received
    February 12, 2008
    Date of Event
    October 19, 2007
    Report Date
    November 6, 2007
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    NURSE

    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, WILL BE CONTACTED AND AN UPGRADE WILL BE INSTALLED TO ENSURE NO FAILURES IN THE FUTURE.

    Description of Event or Problem · 1

    A TECH AT (B) (4) WAS HELPING AN APPROXIMATELY (B) (6) (B) (6) PATIENT TO GET ONTO THEIR VASSCAN TABLE. AS THE PATIENT STARTED TO LAY BACK ON THE TABLE, THE MOUNTING BRACKET HOLDING THE TRENDELENBURG ACTUATOR BROKE OFF THE TABLE TOP FRAME. THIS CAUSED THE HEAD OF THE TABLE TO SUDDENLY DROP TOWARD THE FLOOR. THE PATIENT REACHED UP AND GRABBED THE SHOULDERS OF THE TECH TO KEEP FROM FALLING. THE WEIGHT OF THE PATIENT WAS TOO MUCH FOR THE TECH AND THEY FELL TO THE FLOOR. THIS CAUSED THE TECH TO STRAIN HER BACK. THE PATIENT WAS NOT REPORTED TO BE INJURED BY THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VASSCAN MODEL 2284 GENERAL VASCULAR ULTRASOUND TABLE LGX MEDICAL POSITIONING, INC. 2284

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Other