BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRIS

    MDR report key: 1983111 · Received January 29, 2011

    Report

    Report Number
    1983111
    Event Type
    Malfunction
    Date Received
    January 29, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 29, 2011
    Manufacturer
    PHILIPS MEDICAL SYSTEMS USA, INC.
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT IN INTERVENTIONAL RADIOLOGY - PROCEDURE MATTRESS SLID INTO THE C-ARM CONTROLS, RESULTING IN C-ARM ROTATING DOWNWARD TOWARD PT'S HEAD. TECHNICIAN PROTECTED PATIENT AND WAS ABLE TO MOVE PATIENT AND STRETCHER OUT OF C-ARM PATH, SAVE PATIENT FROM FALLING.ACCORDING TO WITNESSES, THE PATIENT'S HEAD WAS NEARLY STRUCK BY THE MOVING C-ARM AND THERE WASN'T A MEANS TO STOP THE ARM QUICKLY. THE STAFF HAS SUGGESTED VELCRO (OR SOMETHING SIMILAR) APPLIED TO THE MATS SO THAT THEY CAN'T SLIP AND BRUSH THE CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRIS X-RAY SYSTEM, CATH/ANGIO JAA PHILIPS MEDICAL SYSTEMS USA, INC. INTEGRIS *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR