BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAE PEDIATRIC FOAM EAR TIPS

    MDR report key: 7047246 · Received November 20, 2017

    Report

    Report Number
    3018859-2017-00950
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Report Date
    October 24, 2017
    Manufacturer
    NATUS MEDICAL INC.
    Product Code
    GWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ISSUE WAS INVESTIGATED THROUGH CORRECTIVE ACTIONS. THE ROOT CAUSE OF THIS ISSUE WAS CONFIRMED TO BE INADEQUATE APPLICATION OF THE ADHESIVE WHICH SECURES THE FOAM TO THE LUMEN TUBE.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS PROVIDED REPLACEMENT FOAM TIPS, AND PRODUCT RETURNS HAVE BEEN REQUESTED. NATUS INSTRUCTIONS INCLUDE SELECTING THE APPROPRIATE SIZE EAR TIP FOR THE PATIENT, AS WELL AS INSTRUCTIONS REGARDING USING LARGER SIZE FOAM TIPS FOR INSERTION INTO THE EAR CANAL. NATUS IS INVESTIGATING THIS ISSUE THROUGH CORRECTIVE ACTIONS AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO NATUS MEDICAL THAT THE FOAM IS SLIDING OF THE INNER PLASTIC TUBING OF THE FOAM EAR TIP ASSEMBLIES. THERE HAS BEEN NO REPORT OF PATIENT DEATH, INJURY OR DELAY IN PATIENT TREATMENT. NO ENVIRONMENTAL OR SAFETY CONCERNS HAVE ALSO BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824552 OAE PEDIATRIC FOAM EAR TIPS OAE PEDIATRIC FOAM EAR TIPS GWJ NATUS MEDICAL INC. 203211 N032217-04

    Patients

    Seq Age Sex Outcome Treatment
    1 Other