BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOBLUE

    MDR report key: 6896162 · Received September 26, 2017

    Report

    Report Number
    3018859-2017-00732
    Event Type
    Malfunction
    Date Received
    September 26, 2017
    Report Date
    August 28, 2017
    Manufacturer
    NATUS MEDICAL INCORPORATED
    Product Code
    LBI
    PMA / PMN Number
    K160305
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NATUS MEDICAL TECH SUPPORT FOUND THE PRODUCT WAS NOT WITHIN INTENSITY SPECIFICATION. TECH SUPPORT WITH THE USER OVER THE PHONE WAS ABLE TO ADJUST THE UNIT WITHIN SPECIFICATION (USING AN OHMEDA BILIBLANKET METER II) IN ACCORDANCE WITH THE NEOBLUE SERVICE MANUAL (001320 REV. K); BY ADJUSTING THE POTENTIOMETERS TO INCREASE THE INTENSITY. THEREFORE NO FURTHER EXAMINATION OR TESTING IS REQUIRED.

    Description of Event or Problem · 1

    NATUS MEDICAL RECEIVED A COMPLAINT ON (B)(6) 2017 THAT THEIR NEW NEOBLUE 3 HAD LOW INTENSITY. THE CUSTOMER CONFIRMED THAT MEASUREMENTS WERE TAKEN ACCORDING TO THE SERVICE MANUAL WITH A OHMEDA BILI-BLANKET METER II. NO PRIOR INTENSITY ADJUSTMENTS WERE MADE TO THE UNIT. THE CUSTOMER CONFIRMED THERE WAS NO DEATH/SERIOUS INJURY, DELAY IN TREATMENT, OR ENVIRONMENTAL/SAFETY CONCERNS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674289 NEOBLUE NEOBLUE 3 LBI NATUS MEDICAL INCORPORATED 001103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other