BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIORESPIRATORY MONITOR & PULSE OXIMETER

    MDR report key: 26149 · Received August 9, 1995

    Report

    Report Number
    26149
    Event Type
    Death
    Date Received
    August 9, 1995
    Date of Event
    August 3, 1995
    Report Date
    August 7, 1995
    Manufacturer
    NONIN MEDICAL, INC.
    Product Code
    DQA
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    POST-SURGICAL PT (FOOT SURGERY 8/2/95) ON IV FLUIDS, MORPHINE SULFATE DRIP & PT CONTROLLED ANALGESIA (PCA), CARDIORESPIRATORY (CR) MONITOR & OXIMETRY. LAST VISUAL CHECK APPROX 0530. FOUND IN FULL ARREST AT 0630, O2 SATS PER MONITOR: 98%. AT CONCLUSION OF UNSUCCESSFUL RESUSITATION ATTEMPTS, CR MONITOR ALARMS WERE IN OFF POSITION. UNABLE TO DETERMINE IF ALARMS WERE TURNED OFF DURING RESUSITATION, AT SOME POINT PRIOR TO ARREST, OR WERE NOT SET WHEN MONITOR WAS APPLIED TO PT 8/2/95. MDS & RNS FINDING PT IN FULL ARREST STATE NO ALARMS WERE SOUNDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIORESPIRATORY MONITOR & PULSE OXIMETER MONITOR & OXIMETER DQA NONIN MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Death