BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GE LOGIQ E9

    MDR report key: 6180655 · Received December 12, 2016

    Report

    Report Number
    MW5066719
    Event Type
    Injury
    Date Received
    December 12, 2016
    Date of Event
    December 8, 2016
    Report Date
    December 12, 2016
    Manufacturer
    GENERAL ELECTRIC
    Product Code
    IYO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    ONGOING ISSUES WITH 3 GE LOGIQ E9 ULTRASOUND MACHINES PERIODICALLY SHUTTING DOWN DURING PATIENT EXAMS AND NOT REBOOTING. THIS HAS CAUSED A DELAY IN PATIENT EXAMS BEING READ AND IMAGES BEING TRANSFERRED TO THE RADIOLOGIST TO READ THE EXAM WITH ANY ABNORMAL FINDINGS. ALL SHUTDOWNS OCCURRED WITHOUT STAFF INTERVENTION. MACHINES INVOLVED WERE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819146 GE LOGIQ E9 GE LOGIQ E9 IYO GENERAL ELECTRIC LE9201343US6
    819147 GE LOGIQ E9 GE LOGIQ E9 IYO GENERAL ELECTRIC LE9201376US6
    819148 GE LOGIQ E9 GE LOGIQ E9 IYO GENERAL ELECTRIC LE9201388US6

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention