BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARITY HEARING SCREENER

    MDR report key: 2095350 · Received April 26, 2011

    Report

    Report Number
    1419887-2011-00001
    Event Type
    Malfunction
    Date Received
    April 26, 2011
    Report Date
    March 28, 2011
    Manufacturer
    SONAMED CORP (SUBSEQUENTLY/RECENTLY ACQUIRED BY NATUS MEDICAL INC, MUNDELIN, IL)
    Product Code
    GWJ
    PMA / PMN Number
    K952080
    Removal / Correction Number
    Z-2165-2010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED TO NATUS MEDICAL INC THAT AN INFANT BORN ON (B)(6) 2009 WAS SCREENED PER THE WELL BABY PROTOCOL WITH OAE USING THE CLARITY SYSTEM. THE RESULT INDICATING THE CHILD PASSED WAS GENERATED ON THE SONAMED CLARITY UNIT. THE SCREENING WAS PERFORMED BY THE UNIT CLERK PER THE HOSPITAL PROTOCOL. AT (B)(6), PROFOUND BILATERAL SENSORI-NEURAL HEARING LOSS WAS DIAGNOSED AND THE CHILD NOW HAS BILATERAL COCHLEAR IMPLANTS. THIS IS NOT A CASE OF AUDITORY NEUROPATHY WHERE PASSING RESULTS ON OTOACOUSTIC EMISSIONS TESTING WOULD BE THE EXPECTED OUTCOME AND THERE ARE NO RISK INDICATORS FOR HEARING IN THE MEDICAL HISTORY CONFIRMED AT THIS POINT. AFTER PURCHASING SONAMED, NATUS MEDICAL INCORPORATED ENGAGED IN DUE DILIGENCE TO DETERMINE WHETHER THERE WAS ADEQUATE SCIENTIFIC EVIDENCE TO SUPPORT ALL CLAIMS BEING MADE FOR THE PURCHASED SONAMED PRODUCTS. AS A RESULT, NATUS MEDICAL INCORPORATED CONCLUDED THAT THE CLARITY DEVICES CANNOT PERFORM AS INTENDED OR AS REASONABLY EXPECTED AND THEREFORE DECIDED TO RECALL THIS PRODUCT (RECALL #Z-2165-2010).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARITY HEARING SCREENER GWJ SONAMED CORP (SUBSEQUENTLY/RECENTLY ACQUIRED BY NATUS MEDICAL INC, MUNDELIN, IL)

    Patients

    Seq Age Sex Outcome Treatment
    1 Other