BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS

    MDR report key: 1213547 · Received October 27, 2008

    Report

    Report Number
    MW5008785
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    October 10, 2008
    Report Date
    October 27, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS
    Product Code
    IZI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SIEMENS ANGIOSTAR EQUIPMENT WITH CARDIAC CATHETERIZATION MODULE BOOTED UP TO BYPASS MODE. UNABLE UPON REBOOT TO GET EQUIPMENT TO PROVIDE CINE MODE. "FLOUIOSCOPE" ONLY WORKED. "WAS NOT ABLE TO GO FROM LARGEST FOU TO A MODIFIED FOV. BY FLUORO ONLY ABLE TO PLACE A TEMP VENOUS PACEMAKER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS ANGIOSTAR ANGIOGRAPHY EQUIPMENT IZI SIEMENS MEDICAL SOLUTIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Life Threatening