BEUDAMED
    FDA Adverse Event Death Summary report: N

    OPTIMUS CP

    MDR report key: 70517 · Received February 13, 1997

    Report

    Report Number
    1217116-1997-00006
    Event Type
    Death
    Date Received
    February 13, 1997
    Date of Event
    January 14, 1997
    Report Date
    January 14, 1997
    Manufacturer
    PHILLIPS SYSTEME MEDEZIN
    Product Code
    IZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FLUORO FAILED WHILE A CRITICAL PT WAS ON THE TABLE AND FLUORO STILL DID NOT WORK AFTER SYSTEM REBOOT. THE CASE WAS COMPLETED USING DIGITAL AND CINE RUNS. REPORTEDLY, THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMUS CP X-RAY GENERATOR IZO PHILLIPS SYSTEME MEDEZIN NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death