BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE BLANKET

    MDR report key: 6180790 · Received December 16, 2016

    Report

    Report Number
    3018859-2016-00032
    Event Type
    Malfunction
    Date Received
    December 16, 2016
    Report Date
    December 1, 2016
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS MEDICAL INITIATED A FIELD CORRECTIVE ACTION, RECALL NUMBER Z-1412-2015, FOR THE NEOBLUE BLANKET SYSTEMS IN (B)(6) 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. PLEASE NOTE THAT ADDITIONAL INFORMATION INCLUDING DATE OF EVENT WERE REQUESTED FROM THE CUSTOMER AND CUSTOMER HAS NOT RESPONDED TO NATUS WITH REQUIRED INFORMATION.

    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
    832041 NEOBLUE BLANKET NEOBLUE BLANKET LBI NATUS MEDICAL INCORPORATED 006254, 006245 002471, N070313-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Other