BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLEXICAIR MC3

    MDR report key: 223886 · Received April 29, 1999

    Report

    Report Number
    1045510-1999-00003
    Event Type
    Death
    Date Received
    April 29, 1999
    Date of Event
    March 29, 1999
    Report Date
    April 27, 1999
    Manufacturer
    HILL-ROM, INC.
    Product Code
    INX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STAFF CHECKED PATIENT AT 0035 AND FOUND PATIENT SLEEPING. PATIENT CHECKED AGAIN AT 0135 AND WAS FOUND BETWEEN PATIENT'S RIGHT HEAD AND PATIENT'S RIGHT FOOT SIDERAIL, FACING BED WITH KNEES ON FLOOR. PATIENT HAD NO PULSE. HEAD OF BED ELEVATED APPROX 30 DEGREES. NO EYEWITNESSES AVAILABLE. STAFF HAD NOTICED CHANGE IN REPIRATION AND BEHAVIOR OVER LAST FEW DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAIR MC3 LOW AIRLOSS THERAPY INX HILL-ROM, INC. MC3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death