BEUDAMED
    FDA Adverse Event Death Summary report: N

    FLOCARE

    MDR report key: 177916 · Received July 16, 1998

    Report

    Report Number
    177916
    Event Type
    Death
    Date Received
    July 16, 1998
    Date of Event
    June 5, 1998
    Report Date
    July 15, 1998
    Manufacturer
    FLOCARE MEDICAL
    Product Code
    BYD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT INTUBATED ON 6/3/1998 AND ON A VENTILATOR. PT EXPIRED ON 6/5/1998 SECONDARY TO MUCUS PLUG. DISPOSABLE HEAT & MOISTURE EXCHANGER IN USE FROM 6/3/1998 TO 6/5/1998 TO HUMIDIFY. THE EXCHANGER WAS CHANGED EVERY 24 HOURS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLOCARE DISPOSABLE HEAT & MOISTURE EXCHANGER BYD FLOCARE MEDICAL 2023 LF 8868 59

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death