BEUDAMED
    FDA Adverse Event Death Summary report: N

    LNCS DBI

    MDR report key: 3900217 · Received June 18, 2014

    Report

    Report Number
    2031172-2014-00089
    Event Type
    Death
    Date Received
    June 18, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MASIMO CORPORATION
    Product Code
    DQA
    PMA / PMN Number
    K090662
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. ONCE THE INVESTIGATION ON THE UNIT IS PERFORMED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THERE WAS A DISCREPANCY BETWEEN THE ARTERIAL BLOOD AND GAS AND PULSE OX VALUE. SUBSEQUENTLY ON (B)(6) 2014 IN THE CRITICAL CARE UNIT, THE SPO2 WAS READING HIGH AS COMPARED TO THE ABG RESULT. THE PATIENT WAS ON A VENT AND THE FIO2 WAS INCREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358923 LNCS DBI DQA MASIMO CORPORATION DBI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Death PHILLIPS MONITOR| PHILLIPS MONITOR