BEUDAMED
    FDA Adverse Event Injury Summary report: N

    C-ARM II CAMERA

    MDR report key: 370627 · Received January 7, 2002

    Report

    Report Number
    370627
    Event Type
    Injury
    Date Received
    January 7, 2002
    Date of Event
    December 28, 2001
    Report Date
    January 2, 2002
    Manufacturer
    GENERAL ELECTRIC MEDICAL SYSTEMS
    Product Code
    IZI
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS ADMITTED FROM ANOTHER FACILITY WITH AN ACUTE MYOCARDIAL INFARCTION. PT WAS UNDERGOING A CARDIAC CATHETERIZATION. DURING THE PROCEDURE, THE C-ARM CAMERA DROPPED, LANDING ON THE PT'S CHEST. THE CAMERA IS ESTIMATED TO WEIGH 200 LBS. THE CAMERA WAS REMOVED WITHIN 15 SECS. THE PT WAS MOVED TO ANOTHER CATH LAB AND THE PROCEDURE WAS COMPLETED. THE MALFUNCTION OCCURRED WITH THE CHAINS BREAKING. THE GEARBOX COULD HAVE CONTRIBUTED TO THE PROBLEM. EVALUATION PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 C-ARM II CAMERA C-ARM II CAMERA IZI GENERAL ELECTRIC MEDICAL SYSTEMS 2282290 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization