BEUDAMED
    FDA Adverse Event Death Summary report: N

    LNCS NEO ADH SENSOR

    MDR report key: 4193953 · Received October 8, 2014

    Report

    Report Number
    2031172-2014-00315
    Event Type
    Death
    Date Received
    October 8, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K060143
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES.

    Additional Manufacturer Narrative · 1

    MULTIPLE ATTEMPTS FOR PRODUCT RETURN AND REQUESTS FOR ADD'L INFO WERE MADE. THE UNIT HAS NOT BEEN RETURNED TO MASIMO TO ALLOW AN ANALYSIS TO BE PERFORMED. IF NEW INFO IS OBTAINED OR THE DEVICE IS RETURNED, A F/U REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT, "(B)(6), WE WERE UNABLE TO OBTAIN A PULSE OX READING AT ALL, OR WAS GIVING ME A READING IN THE MID 90'S WHEN THIS SAT WAS ACTUALLY MUCH LOWER. WE HAD TO DRAW FREQUENT ABG'S TO MONITOR HIS OXYGEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633054 LNCS NEO ADH SENSOR OXIMETER DQA MASIMO CORPORATION 2329

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death