BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS-MAGALIX CATH PLUS 121GW BI PLANE IMAGING SYSTEM

    MDR report key: 3015724 · Received March 14, 2013

    Report

    Report Number
    MW5029421
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    March 6, 2001
    Report Date
    March 14, 2013
    Manufacturer
    SIEMENS FLUKE-V-451P
    Product Code
    IZO
    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

    (B)(6) CHILD UNDERWENT IR PROCEDURE THAT RESULTED IN AN UNANTICIPATED NEUROLOGIC OUTCOME CAUSED BY EQUIPMENT FAILURE. THIS REPORT WAS COMPLETED (B)(4) 2013 BUT A COPY WAS NOT RETAINED. BASED ON THE ADVICE FROM FDA, A SECOND REPORT WAS DONE TO OBTAIN A COPY FOR MY RECORDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108360 SIEMENS-MAGALIX CATH PLUS 121GW BI PLANE IMAGING SYSTEM FLUOROSCOPY IZO SIEMENS FLUKE-V-451P ARTIS-ZEE DBA 1754

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other| S