BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM MC DETECTORS

    MDR report key: 538218 · Received March 23, 2004

    Report

    Report Number
    9613299-2004-00004
    Event Type
    Malfunction
    Date Received
    March 23, 2004
    Date of Event
    February 26, 2004
    Report Date
    March 23, 2004
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED REGARDING DETECTOR #2 WHICH SLID OUTSIDE ITS MECHANICAL SLOT AND LANDED ON DETECTOR #1. AN INVESTIGATION CONDUCTED ON SITE REVEALED THE FIELD ENGINEER (FE) DROPPED A SERVICE TOOL. IN TRYING TO RETRIEVE THE TOOL THEY RELEASED A MECHANICAL END STOPPER OF THE DETECTOR. THE DETECTOR MOVED THE WHOLE MAXIMUM "IN" TRAVEL WITHOUT ACTIVATING THE LIMIT SWITCH DUE TO THE MISSING MECHANICAL END STOP THAT ALSO ACTIVATED THE LIMIT SWITCH. THE MECHANICAL END STOP WHICH WAS REMOVED JUST PRIOR TO THIS WOULD HAVE STOPPED THE DETECTOR FROM FALLING HAD IT BEEN IN PLACE. SYSTEM WAS OUT OF USE FOLLOWING THE INCIDENT. ROOT CAUSE WAS HUMAN ERROR. NO ONE WAS INJURED AND NO OTHER ADVERSE EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM MC DETECTORS NUCLEAR MEDICINE KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING ASM000525 *

    Patients

    Seq Age Sex Outcome Treatment
    1 NA