BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA PET/MR

    MDR report key: 6527096 · Received April 27, 2017

    Report

    Report Number
    2183553-2017-00006
    Event Type
    Injury
    Date Received
    April 27, 2017
    Date of Event
    January 20, 2016
    Report Date
    July 18, 2017
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    OUO
    PMA / PMN Number
    K142098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION BY GE HEALTHCARE HAS BEEN COMPLETED. ACOUSTIC MEASUREMENTS WERE PERFORMED ON THE PET/MR SYSTEM AND BASED ON THE TESTING COMPLETED, IT WAS CONCLUDED THAT THE PET/MR SYSTEM MET THE (B)(4) REQUIREMENTS AND OSHA LEVELS. THE SYSTEM WAS OPERATING WITHIN THE REGULATORY LIMITS. SYSTEM LOGS WERE REVIEWED AND NO UNUSUAL ERRORS THAT MAY HAVE INDICATED GRADIENT SUBSYSTEM FAILURES OR OTHER CONTRIBUTING FACTORS TO POTENTIAL HIGH ACOUSTIC NOISE WERE IDENTIFIED. THE LIKELY PRIMARY ROOT CAUSE OF THIS EVENT IS A PATIENT MEDICAL CONDITION THAT CAUSED SENSITIVITY TO ACOUSTIC LEVELS. NO SYSTEMIC PRODUCT ISSUE WAS IDENTIFIED. HOWEVER, DUE TO THE ADDITIONAL ENGINEERING INVESTIGATION THAT WAS PERFORMED, THE CUSTOMER¿S GRADIENT COIL WAS REPLACED.

    Additional Manufacturer Narrative · 1

    THERE ARE NO ADDITIONAL DEVICE IDENTIFICATION NUMBERS. TOMOGRAPHIC IMAGER COMBINING EMISSION COMPUTED TOMOGRAPHY WITH NUCLEAR MAGNETIC RESONANCE GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT A PATIENT, WHO WAS WEARING EAR PLUGS, COMPLAINED OF NOT BEING ABLE TO HEAR AFTER A MRI EXAM. THE PATIENT WAS SENT TO THE SITE'S NURSING STATION FOR CARE, HOWEVER NO DETAILS WERE PROVIDED THAT THE PATIENT REQUIRED OR RECEIVED MEDICAL TREATMENT. THE SITE FOLLOWED UP THE FOLLOWING DAY AND THE PATIENT SAID THAT IT HAD IMPROVED BUT NOT FULLY. THE CUSTOMER LATER CONFIRMED THAT THE PATIENT HAD MILD SENSORINEURAL HEARING LOSS AT 2 KHZ IN THE RIGHT EAR. BASELINE HEARING WAS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308347 SIGNA PET/MR TOMOGRAPHIC IMAGER COMBINING OUO GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other