BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAE PEDIATRIC FOAM EAR TIPS

    MDR report key: 7081396 · Received December 4, 2017

    Report

    Report Number
    3018859-2017-01003
    Event Type
    Malfunction
    Date Received
    December 4, 2017
    Report Date
    November 9, 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. FOUR BAGS OF OAE PEDIATRIC FOAM TIPS WERE RETURNED TO NATUS. A TOTAL OF FOUR FOAM TIPS WERE TESTED. UPON VISUAL INSPECTION, ALL OF THE FOAM TIPS ARE SECURELY GLUED TO THE TUBE. SIX OUT OF THE TWELVE FOAM TIPS HAD SEPARATION FROM THE INNER TUBING WHEN PRESSURE WAS APPLIED. 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 TIPS OF THE PEDIATRIC FOAM EAR TIPS ARE SEPARATING FROM THE INNER PLASTIC TUBING. 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
    860764 OAE PEDIATRIC FOAM EAR TIPS OAE PEDIATRIC FOAM EAR TIPS GWJ NATUS MEDICAL INC. 203211 N060217-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other