BEUDAMED
    FDA Adverse Event Death Summary report: N

    THERMOFLO 1/2 HCH MEDIA

    MDR report key: 348168 · Received August 22, 2001

    Report

    Report Number
    348168
    Event Type
    Death
    Date Received
    August 22, 2001
    Date of Event
    August 10, 2001
    Report Date
    August 20, 2001
    Manufacturer
    ARC MEDICAL INC.
    Product Code
    BYD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT SPONTANEOUSLY DISCONNECTED FROM VENT AND "HME" MALFUNCTIONED CAUSING THE VENT NOT TO ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38361 THERMOFLO 1/2 HCH MEDIA COMBINED HEAT ND MOISTURE EXCHANGER/BACTERIA FILTRATION BYD ARC MEDICAL INC. 6001S *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death