BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX SP-4 NUCLEAR SYSTEM

    MDR report key: 221165 · Received April 23, 1999

    Report

    Report Number
    9613299-1999-00002
    Event Type
    Malfunction
    Date Received
    April 23, 1999
    Date of Event
    March 11, 1999
    Report Date
    April 22, 1999
    Manufacturer
    ELGEMS, LTD.
    Product Code
    IYY
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO GEMS THAT THE OPERATOR FAILED TO TIGHTEN THE PLATE TO THE DETECTOR WHEN REPLACING THE COLLIMATOR. THE COLLIMATOR AND PLATE FELL OFF WHEN THE DETECTOR WAS ROTATED OVER THE PT. IT TOUCHED THE PT, BUT THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX SP-4 NUCLEAR SYSTEM NUCLEAR MEDICINE IYY ELGEMS, LTD. SP-4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA