BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MILLENNIUM VG

    MDR report key: 4329331 · Received December 15, 2014

    Report

    Report Number
    9613299-2014-00005
    Event Type
    Injury
    Date Received
    December 15, 2014
    Date of Event
    November 19, 2014
    Report Date
    November 19, 2014
    Manufacturer
    GE MEDICAL SYSTEMS ISRAEL FUNCTIONAL IMAGING
    Product Code
    KPS
    PMA / PMN Number
    K953801
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    SERVICE PERSONNEL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION REVEALED THERE WAS NO DEFECT OF THE SYSTEM INVOLVED OR ITS PLANNED MAINTENANCE SERVICE INSTRUCTIONS. THE SERVICE ENGINEER FAILED TO PROPERLY FOLLOW EHS GUIDELINES, DID NOT OBSERVE THE AREA BEFORE INSERTING HIS HAND AND ALSO DID NOT USE PROPER EQUIPMENT (CUT RESISTANT GLOVES). SERVICE PERSONNEL ARE TRAINED ON NUC SYSTEMS AND EHS GUIDELINES. THESE GUIDELINES INCLUDE USE OF PPE IN THE FORM OF CUT RESISTANT GLOVES FOR FRU REPLACEMENT THAT INVOLVES REPLACEMENT OF PARTS IN TIGHT SPACES THAT HAVE THE POTENTIAL OF PINCHING. THE SERVICE ENGINEER WAS WEARING SURGICAL GLOVES BUT NO CUT RESISTANT GLOVES.

    Additional Manufacturer Narrative · 1

    DATE OF MANUFACTURE UNKNOWN. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A FIELD ENGINEER (FE) WAS PERFORMING PLANNED MAINTENANCE ON A VG SYSTEM AT A CUSTOMER LOCATION. THE FE WAS TIGHTENING A SCREW USING AN ALLEN WRENCH, THE ALLEN WRENCH SLIPPED OFF CAUSING HIS HAND TO COME IN CONTACT WITH A SHARP EDGE. AS A RESULT, THE FE SUSTAINED A CUT ON ONE OF HIS FINGERS, REQUIRING THREE STITCHES AND A TETANUS SHOT. THE FE WAS WEARING SURGICAL GLOVES BUT NO CUT RESISTANT GLOVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    821497 MILLENNIUM VG TOMOGRAPHY COMPUTED EMISSION SYSTEM KPS GE MEDICAL SYSTEMS ISRAEL FUNCTIONAL IMAGING

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other