BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEOBLUE LED PHOTOTHERAPY DEVICE

    MDR report key: 1576551 · Received January 12, 2010

    Report

    Report Number
    3018859-2010-00001
    Event Type
    Injury
    Date Received
    January 12, 2010
    Date of Event
    December 1, 2009
    Report Date
    January 12, 2009
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K022196
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CORRECTIVE ACTION PLANNED AS A RESULT OF THIS REPORT. CUSTOMER WAS SIMULTANEOUSLY USING SIX PHOTOTHERAPY DEVICES WITHOUT PROTECTIVE GLASSES. NO FURTHER ACTION NEEDED.

    Description of Event or Problem · 1

    NICU NURSE MANAGER REPORTED TO NATUS MEDICAL DISTRICT SALES MANAGER ON 12/16/2009 THAT AN EMPLOYEE WAS ON WORKERS COMPENSATION BECAUSE OF EYE/VISION DAMAGE FROM A NEOBLUE NEONATAL PHOTOTHERAPY DEVICE. FOLLOW-UP INFORMATION OBTAINED FROM HOSPITAL PERSONNEL DETERMINED THAT THE NURSE WAS TAKING CARE OF AN INFANT WHO WAS RECEIVING PHOTOTHERAPY SIMULTANEOUSLY FROM MULTIPLE DEVICES: TWO NEOBLUE LIGHTS, TWO OTHER OVERHEAD PHOTOTHERAPY LIGHTS AND TWO BILIBLANKETS. THE NURSE DID NOT WEAR PROTECTIVE GLASSES BECAUSE SHE COULDN'T FIND THEM AT THE TIME. SHE WAS DIAGNOSED WITH INFLAMMATION BEHIND THE RIGHT EYE AND A BLIND SPOT. THE DOCTOR'S EXAMINATION DETERMINED THAT LIGHT EMITTED BY THE NEOBLUE WAS A POSSIBLE CAUSE FOR THE EYE INJURY. THE HOSPITAL REPORTED THAT THE NURSE IS DOING FINE NOW AND WOULD BE RETURNING TO WORK SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEOBLUE LED PHOTOTHERAPY DEVICE NEONATAL PHOTOTHERAPY UNIT LBI NATUS MEDICAL INCORPORATED NEOBLUE 2 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability TWO BILIBLANKETS WERE USED AT THE SAME TIME AS| TWO NEOBLUE DEVICES.| TWO OTHER OVERHEAD PHOTOTHERAPY LIGHTS AND