BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LNCS DBI

    MDR report key: 3976310 · Received June 18, 2014

    Report

    Report Number
    2031172-2014-00086
    Event Type
    Malfunction
    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 CCU, THE SPO2 WAS READING HIGH AS COMPARED TO THE ABG RESULT. THE PATIENT WAS PLACED ON BILEVEL POSITIVE AIRWAY PRESSURE (BIPAP). HE WAS ON 61PM SIMPLE MASK AT 1632 AND WAS PLACED ON BIPAP SOMETIME BEFORE 2ND ARTERIAL BLOOD GAS(ABG) DRAW AT 1740.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358112 LNCS DBI DQA MASIMO CORPORATION DB-I

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male PHILLIPS MONITOR| PHILLIPS MONITOR