BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NM MILLENNIUM MPR COLLIMATOR

    MDR report key: 563044 · Received December 30, 2004

    Report

    Report Number
    9613299-2004-00010
    Event Type
    Injury
    Date Received
    December 30, 2004
    Date of Event
    November 29, 2004
    Report Date
    December 30, 2004
    Manufacturer
    GE MEDICAL SYSTEMS, F.I. HAIFA
    Product Code
    IZX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED CONCERNING A PT NOSE INJURY IN MPR SYSTEM. THE EVENT OCCURRED IN PREPARATION FOR THYROID SCAN WITH LEGP COLLIMATOR. THE USER LOWERED THE DETECTOR HEAD AT NORMAL SPEED, USING THE HAND HELD CONTROLLER WHILE PT WAS LYING ON BED. WITHOUT BEING NOTICED BY THE OPERATOR, THE DETECTOR CAME IN CONTACT TO THE PT NOSE. THE GANTRY MOVEMENT WAS STOPPED UPON PSD ACTIVATION, BUT THE PT NOSE WAS DAMAGED; POTENTIALLY BROKEN. THE SCAN WAS STOPPED AND NO FURTHER SCANS WERE MADE TO THE PT. SYSTEM WAS RECHECKED BY FILED ENGINEERING FOR NORMAL SPD OPERATION (STOP MOTION UPON SLIGHT CONTACT BY THE OPERATOR). THE SYSTEM BEHAVED NORMALLY AND WAS RETURNED TO NORMAL USE ROUTINES FOR THE SAME TYPE OF SCANS WITH OTHER PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NM MILLENNIUM MPR COLLIMATOR COLLIMATOR IZX GE MEDICAL SYSTEMS, F.I. HAIFA NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other