BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEALTHDYNE

    MDR report key: 31996 · Received April 21, 1995

    Report

    Report Number
    31996
    Event Type
    Death
    Date Received
    April 21, 1995
    Date of Event
    April 3, 1995
    Report Date
    April 5, 1995
    Manufacturer
    HEALTHDYNE TECHNOLOGIES, INC.
    Product Code
    FLS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Description of Event or Problem · 1

    PT WAS FOUND UNRESPONSIVE IN BED BY STAFF. STAFF STATES THE APNEA MONITOR WAS TURNED ON, BUT NO AUDIBLE ALARM WAS HEARD. PT ELECTRODES WERE NOT ON PT, BUT STUCK TO THE PT'S BEDDING. MONITOR WAS TURNED OFF AND CPR WAS STARTED. CPR WAS ALMOST IMMEDIATELY STOPPED DUE TO THE PT'S "NO CODE" STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEALTHDYNE APNEA MONITOR FLS HEALTHDYNE TECHNOLOGIES, INC. 900 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death