BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIDIAN 1

    MDR report key: 2153063 · Received June 23, 2011

    Report

    Report Number
    1525965-2011-00035
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 17, 2011
    Manufacturer
    DDD DIAGNOSTIC
    Product Code
    KPS
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE OPERATOR SET UP A SPECT PROTOCOL FOR VENTRAL AND DORSAL IMAGING. AFTER THE VENTRAL IMAGE WAS PERFORMED, THE PATIENT MOVED AND SPREAD/BRACED HER ARM. ACCORDING TO THE PROTOCOL SETUP, THE GANTRY MOVED AUTOMATICALLY FROM THE BOTTOM TO THE TOP TOWARDS DORSAL AND SQUASHED THE PATIENTS ARM. THE X-RAY ASSISTANT WANTED TO STOP THE GANTRY AND SELECTED STOP ON THE IMAGE PROTOCOL OF THE ACQUISITION COMPUTER, BUT THE GANTRY DID NOT STOP THE ROTARY MOVEMENT. THEREON THE X-RAY ASSISTANT PUSHED THE E-STOP BUTTON AND THE GANTRY STOPPED. THE OPERATOR REMOVED THE PATIENT FROM THE GANTRY AND THE PATIENT WAS SENT TO THE HOSPITAL FOR EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MERIDIAN 1 NUCLEAR MEDICINE EQUIPMENT KPS DDD DIAGNOSTIC 9SYS0630, REV A02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other