BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.0T PET/MR

    MDR report key: 4940016 · Received July 24, 2015

    Report

    Report Number
    2183553-2015-00017
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    April 9, 2015
    Report Date
    April 23, 2015
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    OUO
    PMA / PMN Number
    K142098
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT CODE IS OUO. (B)(6). GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION REVEALED THAT THE INCIDENT OCCURRED ON (B)(6) 2015 INSTEAD OF 04/23/2015; A FIELD ENGINEER (FE) SUFFERED HEARING DAMAGE DURING INSTALLATION OF A 3T PET/MR SYSTEM. THE COMPLAINT WAS RAISED AFTER THE FE HAD BEEN IN THE SCAN ROOM, TROUBLESHOOTING ISSUES WITH THE AS-SHIPPED HARDWARE. TWO ISSUES CONTRIBUTED: 1. THE FE WAS NOT WEARING PRESCRIBED HEARING PROTECTION & 2. THE GRADIENT COIL WAS DEFECTIVE. HEARING PROTECTION REQUIREMENTS ARE DOCUMENTED & THE FE HAD COMPLETED APPROPRIATE SAFETY TRAINING. THE ELEVATED ACOUSTIC NOISE LEVEL WAS ISOLATED TO GRADIENT COIL FAILURES. A COMPOUND EFFECT OF SITE CONDITIONS (COLD TEMPERATURES, WEDGE LOCATIONS, HIGH SHIM MASS) MAY HAVE CONTRIBUTED TO THE FAILURE. A REVIEW OF COMPLAINTS FOR ALL DV SYSTEMS DID NOT IDENTIFY ANY OTHER CASES WITH THIS FAILURE MODE. ACOUSTIC NOISE MEASUREMENT SURVEY WAS PERFORMED ON 16 GE HEALTHCARE MR SYSTEMS INSTALLED AT CUSTOMER SITES. THE RESULTS CONFIRMED THAT THEY ALL MET OSHA LEVELS & ARE WITHIN SPECIFICATION. THE ROOT CAUSE FOR THIS INCIDENT WAS SERVICE PROCESSES NOT FOLLOWED, IMPROPER HEARING PROTECTION. MANAGEMENT REINFORCED WITH THE REQUIREMENTS FOR HEARING PROTECTION WITH THE FIELD ENGINEER. NO FURTHER ACTIONS ARE PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    A FIELD SERVICE ENGINEER REPORTED THAT THEY HAD BEEN EXPERIENCING RINGING IN THEIR EARS DUE TO EXPOSURE TO LOUD NOISES FROM AN MR UNIT DURING INSTALLATION. THE FE WAS EVALUATED BY AN ENT PHYSICIAN WHO CONFIRMED THEY HAVE NEW HEARING IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482220 3.0T PET/MR TOMOGRAPHIC IMAGER COMBINING EMISSION COMPUTED TOMOGRAPHY WITH NUCLEAR MAGNETIC OUO GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other| R