BEUDAMED
    FDA Adverse Event Injury Summary report: N

    *

    MDR report key: 778200 · Received October 20, 2006

    Report

    Report Number
    2431314-2006-00001
    Event Type
    Injury
    Date Received
    October 20, 2006
    Date of Event
    June 14, 2006
    Report Date
    August 22, 2006
    Manufacturer
    BIODEX MEDICAL SYSTEMS, INC.
    Product Code
    KXJ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ULTRASOUND TABLE WAS MANUFACTURED IN 03/1992. BIOMED STATED TO BIODEX THAT THE CASTERS LOCK AND THEY NEVER MAINTAINED THE TABLE OR PERFORMED ANNUAL SAFETY INSPECTIONS ON THE TABLE. THE TABLE IS DESIGNED WITH INDIVIDUAL LOCKING CASTERS AND EACH CASTER MUST, THEREFORE, BE LOCKED INDEPENDENTLY OF THE OTHER CASTERS. IN THE INSTRUCTION MANUAL FOR THIS TABLE, IT IS SPECIFIED FOR MAINTENANCE THAT THE CASTERS BE TIGHTENED AND CHECKED PERIODICALLY. THE MANUAL SPECIFIES THAT THE CASTERS SHOULD BE LOCKED BEFORE TRANSFERRING A PT ONTO THE TABLE. WE CONTACTED BIOMEDICAL ENGINEERING AT THE HOSP. THEY INFORMED US THAT THIS TABLE WAS NEVER ON THEIR INSPECTION OR ROUTINE MAINTENANCE SCHEDULE PROVIDED BY THEIR DEPARTMENT. THEY TOLD US THAT EACH CASTER DOES LOCK WHEN INDIVIDUALLY LOCKED. IF CASTERS ARE KEPT CLEAN AND KNOWING THAT THEY CAN LOCK ALL AND BE INDIVIDUALLY LOCKED, THEN EVEN AFTER 14 YEARS, THEY ARE FUNCTIONING. THE CASTERS MAY BE WORN FROM USE OR MAY HAVE BEEN DIRTY AT THE TIME IN QUESTION. THE CASTERS USED IN THIS DESIGN TABLE HAVE BEEN USED ON MEDICAL PRODUCTS BY BIODEX AND OTHER COMPANIES FOR MANY YEARS. BIODEX, IN REVIEWING THIS TABLE INCIDENT, DOES NOT BELIEVE THERE ARE ANY CHANGES REQUIRED FOR THESE TABLES IN THE FIELD OTHER THAN THE FACILITIES NEED TO FOLLOW PROPER MAINTENANCE PROCEDURES WITHIN THEIR OWN FACILITY.

    Description of Event or Problem · 1

    EVENT DESC: PATIENT BROUGHT INTO ROOM IN WHEELCHAIR. PATIENT STOOD UP, WALKED OVER TO PROCEDURE TABLE FOR ULTRASOUND. WHEN SHE TRIED TO SIT ON TABLE, THE TABLE MOVED AND PT FELL TO THE FLOOR FRACTURING BONE IN ARM. THIS HAPPENED DESPITE BRAKES BEING LOCKED. BIOMED DETERMINED THAT BRAKES WERE NOT WORKING APPROPRIATELY. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * TABLE, ULTRASOUND KXJ BIODEX MEDICAL SYSTEMS, INC. 056-605 *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Hospitalization| R