BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEAR MEDICINE GAMMA CAMERA

    MDR report key: 23679 · Received July 25, 1995

    Report

    Report Number
    MW1006556
    Event Type
    Malfunction
    Date Received
    July 25, 1995
    Date of Event
    June 12, 1995
    Report Date
    July 12, 1995
    Manufacturer
    SMV
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE HOSP TECHNOLOGIST STATED THE SYSTEM DROVE INTO A TABLE AND BROKE THE TABLE IN HALF. IT DROVE RIGHT THROUGH THE TABLE. THERE WAS NO INJURY, BUT THE SYSTEM HAS AN UNLIMITED TORQUE SO IT COULD CAUSE AN INJURY. ALSO, THE PT SAFETY SENSOR IS INADEQUATE. THE CO IS CURRENTLY RE-ENGINEERING THE SYSTEMS BUT THEY ARE STILL SHIPPING THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEAR MEDICINE GAMMA CAMERA CAMERA IYX SMV FX40

    Patients

    Seq Age Sex Outcome Treatment
    1 *