BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM MPS

    MDR report key: 1002770 · Received February 26, 2008

    Report

    Report Number
    9613299-2008-00002
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 9, 2008
    Report Date
    January 9, 2008
    Manufacturer
    GEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K951144
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THE GE FIELD ENGINEER (FE) EVALUATED THE SYSTEM AND FOUND THAT THE RETAINING RING THAT HOLDS THE PITCH ACTUATOR MOUNTING IN PLACE WAS RELEASED, CAUSING THE PIN TO BREAK. FURTHER INVESTIGATION REVEALED THAT THE ACTUATOR PIN WOULD BREAK WHILE THE DETECTOR IS IN ITS 90 AND 270-DEGREE POSITIONS, WHICH WOULD PRECLUDE CONTACT WITH THE PT. THE FE REASSEMBLED A NEW RETAINING RING AND PLACED THE SYSTEM BACK IN SERVICE. HISTORICAL REVIEW OF SERVICE RECORD REVEALED NO INDICATIONS OF SERVICE ACTIVITY PERFORMED ON THE SYSTEM THAT WOULD POTENTIALLY LEAD TO THE DAMAGED PIN. THE SYSTEM'S PLANNED MAINTENANCE PROCEDURE CURRENTLY PROVIDES INSTRUCTIONS TO VERIFY THE PITCH ACTUATOR'S FUNCTIONALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MPS SYSTEM'S PITCH ACTUATOR MOUNTING PIN BROKE DURING A PT SCAN, RELEASING THE DETECTOR FROM ITS SUSPENDING MECHANISM. SINCE THE DETECTOR WAS RELEASED FROM A 270-DEGREE POSITION AND THE PT WAS REMOVED BY THE TECHNICIAN, NO PT CONTACT OR INJURY OCCURRED. THE CONCERN IS THAT A SERIOUS INJURY MAY RESULT IF THE DETECTOR WERE TO FALL ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MILLENNIUM MPS NONE KPS GEMS ISRAEL, FUNCTIONAL IMAGING ASM001301 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR