BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MD4 MULTIPURPOSE FLUORO ROOM

    MDR report key: 203705 · Received December 23, 1998

    Report

    Report Number
    MW1015299
    Event Type
    Injury
    Date Received
    December 23, 1998
    Date of Event
    December 10, 1998
    Report Date
    December 23, 1998
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
    Product Code
    JAA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    DURING A MYELOGRAM PROCEDURE IN THE MD4 FLUORO ROOM THE PT WAS LYING IN THE PRONE POSITION. WITHOUT WARNING THE IMAGE - INTENSIFIER (C-ARM) STARTED ANGLING BY ITSELF, TOWARDS THE PT'S BACKSIDE. IT WOULD NOT RESPOND TO LEVERS, SO TECHNOLOGIST PHYSICALLY STOPPED THE ARM AND HIT THE RED EMERGENCY STOP BUTTON. PT WAS PINNED BETWEEN CAMERA AND TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MD4 MULTIPURPOSE FLUORO ROOM FLUORO ROOM JAA PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. 9807-301-01101 *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention