BEUDAMED
    FDA Adverse Event Death Summary report: N

    TOSHIBA IMAGING TABLE

    MDR report key: 477977 · Received July 16, 2003

    Report

    Report Number
    477977
    Event Type
    Death
    Date Received
    July 16, 2003
    Date of Event
    July 1, 2003
    Report Date
    July 16, 2003
    Manufacturer
    TOSHIBA AMERICAN MEDICAL SYSTEM
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT TO HAVE OUTPATIENT PERSANTINE STRESS TEST FOR MYOCARDIAL PERFUSION STUDY. PT FELL FROM IMAGING TABLE AFTER TEST WAS COMPLETED. IMAGING TABLE IN LOWEST POSITION (18 INCHES FROM FLOOR). PLASTIC SIDE ARM SUPPORTS IN PLACE BY PT ARMS. PT STRUCK HEAD ON RIGHT SIDE ON IMAGING CAMERA TRACKING RAIL. PT TRANSFERRED TO EMERGENCY DEPT. COMPLAINT OF HEADACHE WITH RIGHT SHOULDER PAIN. CT OF BRAIN SHOWED LARGE COMPLEX SUBDURAL HEMATOMA WITH MIDLINE SHIFT AND OLD RIGHT CVA. PT MENTAL STATUS DETERIORATED AFTER CT. PT ON COUMADIN. PT 20.7 AND INR 3.42. PT RECEIVED VIT. K 10MG, 4 FRESH FROZEN PLASMA ORDERED AND SENT WITH PT FOR TRANSPORT TO TERTIARY CARE CENTER. PT EXPIRED AT TERTIARY CARE CENTER. IMAGING TABLE HAS 2 VELCRO STRIPS NOTED AT WRONG END OF TABLE TO SECURE THE PLASTIC ARM STABILIZERS WHEN PT LAYS ON TABLE. TABLE NEEDS TO BE EXAMINED FOR PROPER PLACEMENT OF VELCRO RETAINER ARM STABILIZERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA IMAGING TABLE IMAGING TABLE IYX TOSHIBA AMERICAN MEDICAL SYSTEM NBSW700A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death NUCLEAR MEDICINE GAMMA CAMERA IMAGING UNIT 2003.