BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA PET/MR

    MDR report key: 8068619 · Received November 14, 2018

    Report

    Report Number
    2183553-2018-00017
    Event Type
    Injury
    Date Received
    November 14, 2018
    Date of Event
    October 11, 2018
    Report Date
    January 8, 2019
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    OUO
    PMA / PMN Number
    K163619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME: TOMOGRAPHIC IMAGER COMBINING EMISSION COMPUTED TOMOGRAPHY WITH NUCLEAR MAGNETIC RESONANCE. 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. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION BY GE HEALTHCARE HAS BEEN COMPLETED. THE ACOUSTIC PERFORMANCE TEST WAS PERFORMED ON THE SYSTEM AND CONCLUDED THAT THE TESTING MEETS THE IEC 60601-2-33 REQUIREMENTS AND THE OSHA LEVELS ARE WITHIN THE SPECIFICATION FOR THIS SYSTEM CONFIGURATION. THE INCIDENT APPEARS TO BE THE RESULT OF HUMAN MEDICAL CONDITION(S). THE PATIENT WAS PROVIDED SPECIFIED HEARING PROTECTION; HOWEVER, A PATIENT'S MEDICAL CONDITIONS MAY CAUSE SENSITIVITY TO ACOUSTIC LEVELS THAT OCCUR DURING NORMAL CLINICAL SCANNING. NO SYSTEM ISSUE WAS FOUND. NO CORRECTIONS ARE REQUIRED AS THE SYSTEM WAS OPERATING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN MRI OF THE INTERNAL AUDITORY CANALS (IACS) TO EVALUATE A PRE-EXISTING CONDITION OF LEFT SIDED VESTIBULAR SCHWANNOMA AND LEFT SIDE HEARING LOSS. THE PATIENT WAS PROVIDED APPROPRIATE EARPLUGS BY THE CUSTOMER FOR THE EXAM. THE PATIENT RETURNED TO THE RADIOLOGY DEPARTMENT AFTER THE MRI EXAM HAD BEEN COMPLETED TO REPORT HEARING LOSS IN THE RIGHT EAR. THE PATIENT WAS EVALUATED BY THE SITE'S AUDIOLOGY DEPARTMENT WHERE NEW HEARING LOSS IN THE RIGHT EAR WAS CONFIRMED AND MEDICATION WAS PROVIDED FOR TREATMENT. THE PATIENT'S CONDITION IS CONFIRMED TO HAVE FULLY RESOLVED TO PRIOR BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909342 SIGNA PET/MR SEE H10 OUO GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other