BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE

    MDR report key: 6993742 · Received November 1, 2017

    Report

    Report Number
    3018859-2017-00844
    Event Type
    Malfunction
    Date Received
    November 1, 2017
    Report Date
    October 2, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K103589
    Removal / Correction Number
    Z-1412-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS MEDICAL INITIATED A FIELD SAFETY CORRECTIVE ACTION FOR THE NEOBLUE BLANKET SYSTEMS IN APRIL 2015 AS A RESULT OF INVESTIGATIONS CONDUCTED BY NATUS MEDICAL. THESE INVESTIGATIONS SHOWED THAT THIS FAILURE OCCURS AFTER EXTENDED EXPOSURE TO THE INTENSE LIGHT SOURCE WITHIN THE BOX, AT WHICH TIME THE PAD NO LONGER PROVIDES THE THERAPEUTIC TREATMENT FOR WHICH IT IS INTENDED. NATUS IS IN THE PROCESS ON CONFIRMING A NEOBLUE BLANKET CONFIGURATION WHICH WILL NOT BE SUSCEPTIBLE TO THE DEGRADATION DESCRIBED ABOVE.

    Description of Event or Problem · 1

    NATUS MEDICAL RECEIVED INFORMATION REGARDING EARLY DEGRADATION/DISCOLORATION OF THE NEOBLUE BLANKET SYSTEM FIBER OPTIC PADS. THESE FAILURES INVOLVED DISCOLORATION/DEGRADATION FOLLOWED BY EVENTUAL MELTING OF THE FIBER OPTIC BUNDLE AT THE CONNECTOR THAT IS INSERTED IN THE NEOBLUE BLANKET LIGHT BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772919 NEOBLUE NEOBLUE BLANKET LBI NATUS MEDICAL INCORPORATED 006245 N010213-06

    Patients

    Seq Age Sex Outcome Treatment
    1 Other