BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOLECULAR HUMIDITY CHAMBER AND FEED SET

    MDR report key: 10898 · Received January 10, 1994

    Report

    Report Number
    MW1000349
    Event Type
    Injury
    Date Received
    January 10, 1994
    Date of Event
    December 2, 1993
    Report Date
    December 23, 1993
    Manufacturer
    HPD MEDICAL, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS VENTILATOR-DEPENDENT PT WAS NOTED BY A RN TO BE CYANOTIC WITH A MODERATE AMOUNT OF CLEAR FLUID IN HIS VENTILATOR TUBING. VENTILATOR TUBING WAS IMMEDIATELY DISCONNECTED. THE PT WAS SUCTIONED AND GIVEN 100% O2. THE VENTILATOR HUMIDIFIER WAS NOTED TO BE OVERFLOWED WITH STERILE WATER, WHICH BACKED UP INTO THE PT'S TRACH. IT IS UNCLEAR WHETHER THE INCIDENT WAS RELATED TO A CLAMP FAILURE ON THE GRAVITY FEED HUMIDIFIER FILL SET, OR USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MOLECULAR HUMIDITY CHAMBER AND FEED SET BTT HPD MEDICAL, INC. 3000-FS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Life Threatening| R