BEUDAMED
    FDA Adverse Event Death Summary report: N

    GENERAL ELECTRIC MEDICAL SYSTEMS

    MDR report key: 340698 · Received July 2, 2001

    Report

    Report Number
    MW1022332
    Event Type
    Death
    Date Received
    July 2, 2001
    Date of Event
    June 12, 2001
    Report Date
    July 2, 2001
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    FQO
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT JUST COMPLETED PTCA PROCEDURE, REQUESTED BED PAN, AND ROLLED OFF TABLE DURING PLACEMENT OF BED PAN. FALL RESULTED IN RUPTURED SPLEEN, BROKEN RIBS, AND SUBDURAL HEMATOMA. PT DIED IN 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29948 GENERAL ELECTRIC MEDICAL SYSTEMS OMEGA IV ANGIO STEP OPERATING TABLE FQO GENERAL ELECTRIC MEDICAL SYSTEMS ANGIO STEP *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death