BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECLIPSE AUDIOLOGY

    MDR report key: 6099007 · Received November 9, 2016

    Report

    Report Number
    MW5065977
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 20, 2016
    Report Date
    November 9, 2016
    Manufacturer
    INTER ACOUSTICS
    Product Code
    GWJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS SCHEDULED FOR ABR HEARING TEST UNDER ANESTHESIA. THE HEARING TEST EQUIPMENT FAILED. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742421 ECLIPSE AUDIOLOGY ECLIPSE AUDIOLOGY GWJ INTER ACOUSTICS 91029724

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR