BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NATUS

    MDR report key: 1604770 · Received February 11, 2010

    Report

    Report Number
    1604770
    Event Type
    Malfunction
    Date Received
    February 11, 2010
    Date of Event
    February 10, 2010
    Report Date
    February 11, 2010
    Manufacturer
    NATUS MEDICAL INC
    Product Code
    EWO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OR, US

    Narratives

    Description of Event or Problem · 1

    THE NURSES HAVE COMPLAINED MANY TIMES ABOUT THE DIFFICULTY OF USING THE NATUS HEARING SCREENER; ESPECIALLY, THE JELLY TAB SENSORS (ELECTRODES) PROVIDED BY NATUS. THE STAFF HAS TRIED TO USE THE STANDARD ELECTRODES (3M RED DOT). THEY SAW AN IMMEDIATE IMPROVEMENT IN PERFORMANCE. THE STAFF STATED THAT THE SCREEN IS COMPLETED IN HALF THE TIME. THEY HAD LESS DIFFICULTIES WITH KEEPING THE ELECTRODES ATTACHED OR OBTAINING A GOOD SIGNAL. NATUS SENSORS ARE DESIGNED FOR AN INFANT'S SENSITIVE SKIN, BUT DO NOT SEEM TO PERFORM ADEQUATELY. NATUS ELECTRODES ARE NOT OPTIMAL FOR OBTAINING QUALITY RESULTS QUICKLY. THE DEVICE LISTS THE EQUIPMENT AS WELL AS THE NATUS JELLY TAB SENSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NATUS ELECTRODES, INFANT HEARING SCREENER EWO NATUS MEDICAL INC ALGO 2E N0521209-1

    Patients

    Seq Age Sex Outcome Treatment
    1 *