BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HTG CASING

    MDR report key: 519938 · Received March 25, 2004

    Report

    Report Number
    MW1031656
    Event Type
    Malfunction
    Date Received
    March 25, 2004
    Date of Event
    February 22, 2004
    Report Date
    March 10, 2004
    Manufacturer
    G.E. MEDICAL SYSTEMS
    Product Code
    ITY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIAC CATHETERIZATION, A PRESSURE HOSE THAT IS PART OF THE C-ARM TUBE CAUGHT ON A PROTECTIVE SHIELD, PULLED LOOSE, SPRAYING THE PT AND STAFF WITH AN OIL IDENTIFIED AS DIALA OIL M. NO ADVERSE PT OR STAFF OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTG CASING X-RAY TUBE ITY G.E. MEDICAL SYSTEMS 46-239746G26 *

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other