BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIMA MR360

    MDR report key: 2780517 · Received October 5, 2012

    Report

    Report Number
    9613445-2012-00003
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    August 17, 2012
    Report Date
    August 17, 2012
    Manufacturer
    GE HANGWEI MEDICAL SYSTEMS CO
    Product Code
    LNH
    PMA / PMN Number
    K103330
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MR TECHNOLOGIST INFORMATION WAS NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS COMPLETED, THE MAGNET QUENCH WAS SPONTANEOUS AND COULD BE CAUSED WHEN THE BALANCE INSIDE OF SUPERCONDUCTOR HAS BEEN BROKEN, SUCH AS SUDDEN COILS MOVEMENT, COUPLED CURRENT OR MAGNETIC FIELD FROM OUTSIDE, HELIUM PRESSURE INCREASE, HIGHER EM (ELECTRO-MAGNETIC) FORCE FROM OUTSIDE (SUCH AS ELEVATOR MOVEMENT, HEAVY TRUCKS NEARBY AND ETC), QPS (QUENCH PROTECTION SWITCH) FAILURE, ETC. VISUAL INSPECTION AND THE TEST RESULTS FOR THE MIR SYSTEM SHOW NO ISSUES, THE SYSTEM WAS DETERMINED TO BE FUNCTIONING WITHIN SPECIFICATIONS. THE ROOT CAUSE TO THE MR TECHNOLOGIST HEARING LOSS WAS FAILURE OF CUSTOMER OWNED QUENCH VENT. THE CUSTOMERS VENT WAS NOT CONSTRUCTED TO SPECIFICATIONS. UNDER A SPONTANEOUS MAGNET QUENCH EVENT, THE VENT FAILED ALLOWING SOME HELIUM AND RELATED ACOUSTIC ENERGY INTO THE SCAN ROOM. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN MR RADIOGRAPHER COMPLAINT OF HEADACHES FROM A MAGNET QUENCH FROM AN OPTIMA MR360 MR SYSTEM. THE TECHNOLOGIST INFORMED GE HEALTHCARE THAT THEY UNDERWENT AN ENT (EAR, NOSE AND THROAT) EXAM, AND IT WAS DETECTED THE RADIOGRAPHER SUFFERED FROM HYPERACUSIS (OVER SENSITIVITY TO CERTAIN FREQUENCY RANGES). THE HYPERACUSIS OCCURRED PRIOR TO THIS INCIDENT HOWEVER THE TECHNOLOGIST WAS UNAWARE. THE QUENCH GENERATED A SLIGHT HEARING LOSS FOR THE TECHNOLOGIST, IT WAS TREATED WITH CORTISONE AND THE TECHNOLOGIST HEARING IS NOW BACK TO NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTIMA MR360 MAGNETIC RESONANCE DIAGNOSTIC DEVICE LNH GE HANGWEI MEDICAL SYSTEMS CO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other