BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA EXPLORER

    MDR report key: 17165190 · Received June 20, 2023

    Report

    Report Number
    3010949642-2023-00005
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    March 24, 2023
    Report Date
    July 20, 2023
    Manufacturer
    GE HEALTHCARE (TIANJIN) COMPANY LIMITED
    Product Code
    LNH
    PMA / PMN Number
    K143251
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 UNIQUE IDENTIFIER: (B)(4). 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. H3 OTHER TEXT : DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 0

    H3: GE HEALTHCARE'S (GEHC) INVESTIGATION HAS BEEN COMPLETED. WHILE THE FIELD ENGINEER WAS ATTEMPTING TO PERFORM DE-ICING ON THE MR SYSTEM, HIGH PRESSURE LIQUID CRYOGEN SPILLED ON THE FEÂS HANDS AFTER PULLING OUT A RAMPING ROD IN ADDITION TO THE REFLEX ACTION OF TRYING TO REPLACE THE CAP. IT WAS DETERMINED THAT THE FE DID NOT FOLLOW THE PROCEDURE FOR MAXIMUM MAGNET PRESSURE AS THE TASK WAS PERFORMED AT A PRESSURE THAT WAS ABOVE THE MAXIMUM ALLOWABLE LIMIT. ADDITIONALLY, THE APPROPRIATE PERSONAL PROTECTION EQUIPMENT (PPE) WAS NOT USED WHEN PERFORMING THE DE-ICING PROCEDURE. THESE PROCESSES ARE ADDRESSED THROUGH MULTIPLE TRAINING COURSES. THE SYSTEM IS OPERATIONAL AND COMPLIANT. AT THIS TIME, NO ADDITIONAL ACTIVITIES ARE PLANNED BY GEHC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A HELIUM FILL, A GE HEALTHCARE FIELD ENGINEER (FE) SPILLED LIQUID HELIUM ON THEIR FINGERS. THE FE IMMEDIATELY FOLLOWED RELEVANT FIRST AID FOR CRYOGEN BURNS. LATER, INFORMATION WAS RECEIVED THAT THE FE WAS SEEN BY A PHYSICIAN WHO DIAGNOSED THE INJURY AS THIRD-DEGREE BURNS. THE PHYSICIAN COMPLETED DEBRIDEMENT OF THE AREA, DRESSED THE BURNS, AND PROVIDED PAIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462921 SIGNA EXPLORER NUCLEAR MAGNETIC RESONANCE IMAGING LNH GE HEALTHCARE (TIANJIN) COMPANY LIMITED

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other