BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT MONITOR DEVICE

    MDR report key: 33914 · Received July 5, 1996

    Report

    Report Number
    MW1009445
    Event Type
    Injury
    Date Received
    July 5, 1996
    Date of Event
    June 14, 1996
    Report Date
    June 24, 1996
    Manufacturer
    SPACELABS MEDICAL, INC.
    Product Code
    MHX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AL, US
    Reporter Occupation
    DENTIST

    Narratives

    Description of Event or Problem · 1

    PT WAS POST CARDIAC ARREST AND ON RESPIRATOR. ROUTINE MORNING BLOOD GAS DRAWN - REVEALED PO 43. MONITOR SHOWING SAO2 94%. BLOOD GAS REPEATED STAT - SHOWED PO 42.5. ANOTHER PULSE OX PLACED ON PT AND SHOWED SAO2 83%.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PATIENT MONITOR DEVICE PATIENT MONITOR DEVICE MHX SPACELABS MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R