BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMBIA T2

    MDR report key: 3836228 · Received May 20, 2014

    Report

    Report Number
    1423253-2014-00002
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS USA, INC.
    Product Code
    IYX
    PMA / PMN Number
    K131634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A PT PRESENTED FOR A NUCLEAR MEDICINE SCAN WITH A PREEXISTING CONDITION; PARALYSIS OF THE RIGHT ARM. THE PT WAS POSITIONED FOR A BRAIN SCAN. DURING THE SCAN, THE PT'S RIGHT ARM/HAND MOVED INTO THE PATH OF THE MOVING SYSTEM PARTS. THE HAND/ARM WAS CAUGHT DURING THE MOVEMENT AND THE RADIAL BONE IN THE RIGHT ARM DURING THE MOVEMENT AND THE RADIAL BONE IN THE RIGHT ARM WAS BROKEN. THERE WAS NO DEVICE FAILURE OR MALFUNCTION. THE PRODUCT LABELING ADEQUATELY INSTRUCTS THE USERS TO MONITOR PATIENTS AT ALL TIME WHILE IN MOTION TO AVOID ANY RISK OF INJURY. THE PRODUCT LABELING ADEQUATELY DESCRIBES POSITIONING THE PT AND THAT BEFORE SYSTEM MOVEMENT, THE USER MUST VERIFY THAT THE PT OR PEOPLE IN THE AREA ARE CLEAR OF CONTACT, AND THAT THE SYSTEM CAN TRAVEL WITHOUT ITS MOVEMENTS BEING OBSTRUCTED. THE LABELING ADEQUATELY DESCRIBES THAT THE USER MAY CONSIDER USING ARMREST ACCESSORIES TO ASSIST WITH ARM POSITIONING TO AVOID SYSTEM CONTACT. THE EVENT OCCURRED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298654 SYMBIA T2 GAMMA CAMERA IYX SIEMENS MEDICAL SOLUTIONS USA, INC. 10275008

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Required Intervention