BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOPHA NUC CAMERA

    MDR report key: 78796 · Received January 29, 1997

    Report

    Report Number
    78796
    Event Type
    Malfunction
    Date Received
    January 29, 1997
    Date of Event
    November 2, 1996
    Report Date
    November 12, 1996
    Manufacturer
    SOPHA/SMV AMERICA
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE NUCLEAR MEDICINE TECH SET UP THE CAMERA FOR PIN HOLE IMAGES. HER FIRST ATTEMPTED IMAGES WOULD NOT ACQUIRE ANY COUNTS. SHE EXITED THE PROGRAM, CHOSE PROTOCOL AGAIN BUT WHEN SHE CHOSE THE STATIC IMAGE BUTTON, THE CAMERA STARTED ROTATING. THE TECH QUICKLY PRESSED THE RED EMERGENCY STOP BUTTON, BUT THE CAMERA KEPT MOVING. THE TECH RUSHED TO MOVE THE PT AWAY FROM THE CAMERA. THE CAMERA HAD ROTATED ENOUGH TO PUT SOME PRESSURE ON THE PT'S CHEST CAUSING A CHEST CONTUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOPHA NUC CAMERA NUCLEAR MEDICINE CAMERA IYX SOPHA/SMV AMERICA DS7 *

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Other