BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA PETMR

    MDR report key: 6234046 · Received January 9, 2017

    Report

    Report Number
    2183553-2017-00001
    Event Type
    Injury
    Date Received
    January 9, 2017
    Date of Event
    November 16, 2016
    Report Date
    January 26, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE¿S INVESTIGATION IN 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 SIGNA PET/MR SYSTEM LIMITS ACOUSTIC NOISE, WHEN HEARING PROTECTION IS USED. THE SYSTEM OPERATOR IS RESPONSIBLE FOR PROVIDING THE HEARING PROTECTION. IN THIS CASE, HEARING PROTECTION WAS PROVIDED AND PLACED BY THE PATIENT. THE SYSTEM ACOUSTIC LEVEL WAS TESTED TO MEET LOCAL REGULATIONS. NO SYSTEMIC 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 UNDERGOING A PETMR EXAM COMPLAINED OF RIGHT EAR PAIN AND HEARING LOSS. THE HEARING LOSS WAS LATER CONFIRMED BY A PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16347 SIGNA PETMR TOMOGRAPHIC IMAGER COMBINING EMISS OUO GE MEDICAL SYSTEMS, LLC SIGNA PETMR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other