BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMEGA IV

    MDR report key: 568402 · Received January 26, 2005

    Report

    Report Number
    9615727-2005-00002
    Event Type
    Death
    Date Received
    January 26, 2005
    Date of Event
    January 12, 2005
    Report Date
    January 26, 2005
    Manufacturer
    GE MEDICAL SYSTEMS SCS
    Product Code
    IZI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A PT HAD JUST HAD A CARDIAC INTERVENTIONAL EXAMINATION ON THE INNOVA CARDIAC SYSTEM. DIRECTLY AFTER THE EXAMINATION WAS CONCLUDED REPORTEDLY THE PT WAS MOVED TO, OR WAS ASKED TO REMOVE TO THE TROLLEY ADJACENT TO OMEGA IV CARDIAC TABLE BY THE X-RAY STAFF PRESENT. DURING THE TRANSFER FROM TABLE TO TROLLEY THE PT PUSHED ON THE SIDE OF THE OMEGA TABLE EITHER DUE TO BEING OFF-BALANCE OR TO MOVE ONTO THE TROLLY. THEIR PUSH ON THE SIDE OF THE TABLE OVERCAME THE ELECTRO-MAGNETIC BRAKE PRESSURE AND REPORTEDLY THE TABLE MOVED AWAY FROM THE PT AND THE TROLLEY. THE PT FELL BETWEEN THE TABLE AND THE TROLLEY. SOME POINT SUBSEQUENT TO THE FALL THE PT DIED. IT IS NOT CLEAR AT THE TIME OF THE INCIDENT WHETHER THE DEATH WAS CAUSED BY THE FALL, OR WHETHER BEING OFF-BALANCE AND THE HEAVY PUSH TO THE TABLE SIDE WAS A SYMPTOM OF SOME PT PROBLEM, OR WHETHER THE PT'S ALLEGED AGITATION WHILE ON THE TABLE PRIOR TO GETTING ON THE TROLLEY WAS A SYMPTOM OF SOME PREEXISTING PT CONDITION THAT RESULTED IN DEATH. SUBSEQUENT COMMUNICATIONS WITH THE MHRA HAVE INDICATED THAT CAUSE OF DEATH WAS NOT ATTRIBUTED TO THE DEVICE. THE INCIDENT WAS INVESTIGATED AT THE SITE. IT WAS FOUND THAT THE BREAKAWAY FORCE ON THE TABLE IN QUESTION WAS LESS THAN INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OMEGA IV CARDIAC TABLE IZI GE MEDICAL SYSTEMS SCS 2320221 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death