BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIEMENS ANGIOSTAR MEGALIX

    MDR report key: 358172 · Received October 24, 2001

    Report

    Report Number
    MW1023190
    Event Type
    Other
    Date Received
    October 24, 2001
    Date of Event
    September 4, 2001
    Report Date
    October 15, 2001
    Manufacturer
    SIEMENS MEDICAL
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    92.3 MINS OF FLUOROSCOPIC TIME AND 20 CINE RUNS WERE USED DURING A DIFFICULT CARDIAC CATHETERIZATION. PHYSICIST HAS SUBSEQUENTLY DETERMINED THE DOSE ESTIMATE TO BE 366 RADS FROM THE FLUORO AND 81 RADS FROM THE CINE RUNS FOR A TOTAL OF LESS THAN 450 RADS. NO ERYTHEMA OR SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47788 SIEMENS ANGIOSTAR MEGALIX FLUOROSCOPIC SYSTEM JAA SIEMENS MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other 2) BENTSEN WIRE, JR4, JL4.| 1) IMA CATHETERS (5&6FR),