BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA EXPLORER

    MDR report key: 5496126 · Received March 11, 2016

    Report

    Report Number
    3010949642-2016-00001
    Event Type
    Injury
    Date Received
    March 11, 2016
    Date of Event
    February 10, 2016
    Report Date
    April 13, 2016
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K143251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER NARRATIVE: GE HEALTHCARE PERFORMED A CHECKOUT OF THE DEVICE AND FOUND THE SCREW ("M16") STUD AND SCREW HOLES OF THE THREE-LEG JIG TOOL HAD A THREAD GALLING ISSUE MAKING IT DIFFICULT TO ROTATE THE HANDLE. THE FIELD ENGINEERS APPLIED A LARGE FORCE TO THE HANDLE WHICH CAUSED TWO OTHER SCREWS ("M4") ON THE HANDLE TO BREAK. THE M16 SCREW STOCK HAS BEEN CHECKED AND NO ISSUES WERE FOUND. IT WAS CONFIRMED THAT OTHER UNITS SHIPPED TO THE FIELD DO NOT HAVE THE ISSUE. SERVICE PROCEDURES INCLUDES PROPER INSTRUCTIONS FOR USING THE TOOL. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION COULD NOT BE PROVIDED DUE TO COUNTRY PRIVACY LAWS. (B)(4). THE DEVICE WAS NOT BEING OPERATED AT THE TIME OF THIS INCIDENT. THE INITIAL REPORTER IS LOCATED OUTSIDE THE U.S., AND THEREFORE THIS INFORMATION IS NOT PROVIDED DUE TO COUNTRY PRIVACY LAWS. 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

    DURING THE UPGRADE OF THE DEVICE, TWO FIELD ENGINEERS WERE LOOSENING THE THREE-LEG JIG WHEN A PIECE OF THE JIG HANDLE BROKE OFF AND HIT ONE OF THE FIELD ENGINEER'S FACE CAUSING AN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152540 SIGNA EXPLORER NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other