BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA EXPLORER

    MDR report key: 11804970 · Received May 11, 2021

    Report

    Report Number
    3010949642-2021-00004
    Event Type
    Injury
    Date Received
    May 11, 2021
    Date of Event
    April 12, 2021
    Report Date
    August 17, 2021
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K143251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: THE INVESTIGATION BY GE HEALTHCARE (GEHC) HAS BEEN COMPLETED. BASED ON THE INFORMATION PROVIDED, THE INCIDENT OCCURRED DURING A SYSTEM UPGRADE. THE FIELD ENGINEER (FE) CONTACTED A CONTRACTOR TO CREATE A NON-MAGNETIC PIT LID, BUT INSTEAD OF WAITING FOR THE NON-MAGNETIC LID, THE FE MADE THE DECISION TO CONTINUE WITH A MAGNETIC LID. AFTER THE FE FINISHED SYSTEM CALIBRATION AND JUST BEFORE TURNING THE SYSTEM OVER TO THE CUSTOMER FOR APPLICATION TRAINING, THE FE REALIZED HE RE-INSTALLED THE FERROUS LID SO HE RUSHED TO TAKE IT OUT OF THE SCAN ROOM WHEN IT WAS ATTRACTED TO MAGNET. THE FE RELEASED THE LID WITH HIS LEFT HAND BUT MAINTAINED HIS HOLD WITH HIS RIGHT HAND. THE FE INJURED HIS HAND WHEN IT GOT CAUGHT BETWEEN THE FERROUS LID AND THE MAGNET. THE MAGNET WAS RAMPED DOWN TO FACILITATE THE REMOVAL OF THE LID. THIS FERROUS LID WAS LABELED AND TAKEN OUT OF SCAN ROOM. THE ROOT CAUSE WAS DETERMINED TO BE A USER ISSUE AS THE FE DID NOT FOLLOW STANDARD SAFETY PROCEDURES. THE MR SERVICE SAFETY MANUAL AND INSTALLATION MANUAL CLEARLY DEFINE THE RISKS ASSOCIATED WITH ENTERING THE SCAN ROOM WITH FERROUS MATERIALS WHEN THE MAGNET IS AT FIELD. NO FURTHER ACTIONS ARE PLANNED BY GEHC.

    Additional Manufacturer Narrative · 1

    UNIQUE IDENTIFIER: (B)(4). THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. 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 DURING A SYSTEM UPGRADE, THE GE FIELD ENGINEER WAS CHANGING THE CABLE PIT LID AND BROUGHT ONE FERROUS LID INTO THE MAGNET ROOM. WHILE ATTEMPTING TO REMOVE THE LID FROM THE SCAN ROOM, IT BECAME ATTRACTED TO THE MAGNET, LACERATING HIS FINGER IN THE PROCESS. THE LACERATION REQUIRED TWO STITCHES. ADDITIONALLY, HIS FINGERNAIL WAS PIERCED TO DRAIN THE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700921 SIGNA EXPLORER NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other