BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEOBLUE 3 PHOTOTHERAPY DEVICE

    MDR report key: 2869721 · Received December 10, 2012

    Report

    Report Number
    3018859-2012-00006
    Event Type
    Other
    Date Received
    December 10, 2012
    Date of Event
    November 7, 2012
    Report Date
    December 10, 2012
    Manufacturer
    NATUS MEDICAL
    Product Code
    LBI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS MEDICAL INCORPORATED IS CONTINUING TO INVESTIGATE THIS EVENT OT VERIFY THAT THERE IS NO ALLEGED INJURY TO THE PATIENT. A FOLLOW UP REPORT WILL BE SUBMITTED AS FURTHER INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    NURSE COMPLAINED THAT BABY LOOKED GRAY DURING PHOTOTHERAPY TREATMENT WHILE USING THE NEOBLUE PHOTOTHERAPY DEVICE. REPORTS ARE THAT THE GREYNESS RESOLVED OVER A COUPLE OF HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOBLUE 3 PHOTOTHERAPY DEVICE NEOBLUE LBI NATUS MEDICAL 001103 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other