BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OAE PEDIATRIC FOAM EAR TIPS

    MDR report key: 6960093 · Received October 18, 2017

    Report

    Report Number
    3018859-2017-00798
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Report Date
    September 18, 2017
    Manufacturer
    NATUS MEDICAL INC.
    Product Code
    GWJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER WAS ABLE TO RETURN THE DEFECTIVE UNTIS TO NATUS. THE FOAM TIPS WERE SEPARATED FROM THE TUBING UPON INTIAL VISUAL INSPECTION. 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.

    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.

    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 PLASTIC TUBING. THE FOAM TIP SEPARATED AS THE PROBE AND TIP WERE REMOVED FROM THE PATIENT'S EAR. THE CUSTOMER ALSO STATED THIS IS THE FIRST TIME THEY'VE SEEN THIS HAPPEN WITH THE FOAM EAR TIPS. 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
    737692 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