BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MILLENNIUM MG

    MDR report key: 5104880 · Received September 25, 2015

    Report

    Report Number
    9613299-2015-00009
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    August 28, 2015
    Report Date
    August 28, 2015
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K962738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THE PATIENT INJURY OCCURRED AS A RESULT OF MULTIPLE USE ERRORS: 1. THE OPERATOR PERFORMED A SCAN WITH THE PATIENT TABLE LOCATED IN AN UNAPPROVED POSITION, NOT IN FRONT OF THE GANTRY. 2. THE OPERATOR DID NOT FOLLOW THE INSTRUCTIONS TO MONITOR THE POSITION OF THE PATIENT AND EQUIPMENT DURING SCAN PROCEDURES. IN ADDITION, CLEARANCE AREA WAS NOT MARKED ON THE FLOOR. EXISTENCE OF SUCH MARKING WOULD ENABLE THE OPERATOR TO NOTICE THAT THE TABLE IS WITHIN THE GANTRY AREA WHERE DETECTORS ARE ROLLING. THE COSTUMER REFUSED (DURING INSTALLATION) TO SET THE YELLOW MARKS ON THE FLOOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT TABLE WAS POSITIONED LENGTHWISE IN THE RADIAL AXIS OF DETECTORS. THE PRE-PROGRAMMED "PATIENT RELEASE" MOTION WAS INITIATED AND THE DETECTOR CONTACTED THE PATIENT'S HEAD PRIOR TO THE PATIENT BEING MANUALLY REMOVED. THE DETECTOR THEN CONTINUED MOVEMENT UNTIL IT CONTACTED THE TABLE; DAMAGING THE DETECTOR COVER. THE PATIENT WAS SENT TO THE ER FOR A CT SCAN WHICH REVEALED BRUISING, BUT NO BROKEN BONES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635902 MILLENNIUM MG TOMOGRAPHY, COMPUTED, EMISSION KPS GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING NMH801

    Patients

    Seq Age Sex Outcome Treatment
    1