BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISCOVERY LS

    MDR report key: 3936137 · Received June 23, 2014

    Report

    Report Number
    2126677-2014-00011
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K010641
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE SERVICING A DISCOVERY LS PET SYSTEM, A FIELD ENGINEER (FE) WAS REMOVING THE DUMMY PIN (D-PIN) OUT OF A T-RING WHILE IT WAS DISABLED. WHEN THE FE REACHED TO REMOVE THE D-PIN, THE T-RING MOVED CAUSING A LACERATION TO THEIR RIGHT MIDDLE FINGER. THE FE RECEIVED STITCHES AND PRESCRIPTION MEDICATION FOR THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364891 DISCOVERY LS X-RAY, TOMORAPHY, COMPUTED JAK GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other