BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA EXPLORER

    MDR report key: 19282187 · Received May 9, 2024

    Report

    Report Number
    3010949642-2024-00002
    Event Type
    Injury
    Date Received
    May 9, 2024
    Date of Event
    March 31, 2024
    Report Date
    June 28, 2024
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K143251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B4; G1, 3, 6; H2. CORRECTED DATA: D4 PRIMARY UDI NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    A1, 2, 3, 4, 5, 6: PATIENT INFORMATION WAS REQUESTED BUT THE CUSTOMER REFUSED TO PROVIDE DETAILS AS PER THEIR OWN POLICY. D: THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. H3, 6: GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 0

    GE HEALTHCAREÂS (GEHC) INVESTIGATION HAS BEEN COMPLETED. AN EMPLOYEE SUFFERED A CUT ON THEIR HAND REQUIRING SUTURES WHEN A SMALL O2 CYLINDER WITH STAND WAS BROUGHT INTO THE SCAN ROOM AND BECAME ATTRACTED TO THE MAGNET. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. THE TRAINED TECHNICIAN WAS NOT AT THE SITE WHEN THE EVENT OCCURRED. TRAINED PERSONNEL SHOULD BE PRESENT AT ALL TIMES DURING THE OPERATION OF THE MR SYSTEM. GEHCÂS MR SERVICE SAFETY AND INSTALLATION MANUALS DEFINE THE RISKS ASSOCIATED WITH ENTERING THE SCAN ROOM WITH FERROUS MATERIALS IN ADDITION TO PROCEDURES TO FOLLOW TO MAINTAIN CONTROLLED ACCESS TO THE MR SCAN ROOM, AND REDUCE THE LIKELIHOOD OF FERROUS OBJECTS ENTERING IT. NO FURTHER ACTIONS ARE PLANNED BY GEHC. CORRECTED DATA DEVICE IDENTIFICATION NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SMALL O2 CYLINDER WITH STAND WAS BROUGHT INTO THE SCAN ROOM BY A WARD STAFF EMPLOYEE WHEN IT BECAME ATTRACTED TO THE MAGNET. DURING THE ATTRACTION, THE EMPLOYEE SUFFERED A CUT ON THEIR HAND WHICH REQUIRED SUTURES. THE CUSTOMER REMOVED THE O2 CYLINDER ON THEIR OWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520878 SIGNA EXPLORER NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other