BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAT-350B TABLE, CPU CONTROL, W/STEP PIVOT

    MDR report key: 675813 · Received January 26, 2006

    Report

    Report Number
    675813
    Event Type
    Injury
    Date Received
    January 26, 2006
    Date of Event
    January 7, 2006
    Report Date
    January 23, 2006
    Manufacturer
    TOSHIBA AMERICAN MEDICAL SYSTEMS, INC.
    Product Code
    KXJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT FELL FROM SPECIALS (SPECIAL PROCEDURES) TABLE IN RADIOLOGY. PT WITH IMPAIRED LEVEL OF CONSCIOUSNESS. PATIENT DEMONSTATED CHANGE IN MOVEMENT OF LEFT UPPER EXTREMITY (AFTER PROCEDURE FINISHED); FALLING TOWARD STAFF MEMBER WHO WAS IN DIRECT CONTACT WITH THE PATIENT. STAFF ATTEMPTED TO HOLD PATIENT, WHOSE WEIGHT WAS GREATER THAT 250 POUNDS, ATTEMPTING TO MOVE PATIENT BACK TOWARD CENTER OF TABLE. THE BREAKS WERE SET PRIOR TO INCIDENT. TABLE MOVED WITH PATIENT FALLING FORWARD AND STAFF MEMBER WAS UNABLE TO HOLD THE PATIENT'S WEIGHT AND PATIENT FELL TO FLOOR. AWAITING WRITTEN FOLLOW UP REPORT FROM TOSHIBA REGARDING PM (PREVENTIVE MAINTENANCE) AND CHECK AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAT-350B TABLE, CPU CONTROL, W/STEP PIVOT TABLE, RADIOLOGY KXJ TOSHIBA AMERICAN MEDICAL SYSTEMS, INC. CAT-350B UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention