BEUDAMED
    FDA Adverse Event Other Summary report: N

    VASSCAN TABLE MODEL 2184

    MDR report key: 1032483 · Received February 12, 2008

    Report

    Report Number
    1932056-2007-00005
    Event Type
    Other
    Date Received
    February 12, 2008
    Date of Event
    December 13, 2007
    Report Date
    December 28, 2007
    Manufacturer
    MEDICAL POSITIONING, INC.
    Product Code
    LGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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, WILL BE CONTACTED AND AN UPGRADE WILL BE INSTALLED TO ENSURE NO FAILURES IN THE FUTURE.

    Description of Event or Problem · 1

    VASSCAN TABLE "BROKE" AS THE PATIENT WAS GETTING ONTO THE TABLE. THIS MODEL HAS FOWLER POSITIONING (THE ABILITY TO LIFT THE HEAD OF THE PATIENT FROM THE WAIST). AS THE PATIENT LAID DOWN ON THE BED, THE FOWLER ACTUATOR MOUNT ON THE UNDER SIDE OF THE TABLE BROKE AWAY. THIS CAUSED THE HEAD END OF THE TABLE TO FALL TO THE FLOOR. THE PATIENT FELL TO THE FLOOR ALSO. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM FOR EVAL BUT NO INJURIES HAVE 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