BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE

    MDR report key: 7016424 · Received November 9, 2017

    Report

    Report Number
    3018859-2017-00880
    Event Type
    Malfunction
    Date Received
    November 9, 2017
    Report Date
    October 11, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS MEDICAL RESOLVED THE ISSUE WITH A REPLACEMENT LED PANEL. NATUS HAS REQUESTED ADDITIONAL INFORMATION FROM CUSTOMER FOR FURTHER INVESTIGATION. ONCE INVESTIGATION HAS BEEN COMPLETED NATUS WILL PROVIDE A SUPPLEMENTAL REPORT REPORT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO NATUS THAT THEIR 6YR OLD NEOBLUE LIGHT WAS FOUND TO BE AT THE EDGE OF THE SPECIFICATION LIMIT DURING PREVENTIVE MAINTENANCE AND INTENSITY WAS UNABLE TO BE ADJUSTED FURTHER. THE CUSTOMER CONFIRMED NO PATIENT INVOLVEMENT, DELAY IN TREATMENT, OR ENVIRONMENTAL/SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794735 NEOBLUE NEOBLUE LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1