BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS

    MDR report key: 200549 · Received December 4, 1998

    Report

    Report Number
    MW1015111
    Event Type
    Malfunction
    Date Received
    December 4, 1998
    Date of Event
    November 18, 1998
    Report Date
    November 24, 1998
    Manufacturer
    SIEMENS MEDICAL SYSTEMS
    Product Code
    IZJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A LEFT HEART CATHETERIZATION THE FLUOROSCOPY AND CINE WERE NOT FUNCTIONAL. PT WAS MOVED TO ANOTHER ROOM WITH NO HARM RESULTING TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS FLUORO IZJ SIEMENS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other