BEUDAMED
    FDA Adverse Event Death Summary report: N

    AQUA PAK HUMIDIFIER

    MDR report key: 552876 · Received October 29, 2004

    Report

    Report Number
    2014730-2004-00010
    Event Type
    Death
    Date Received
    October 29, 2004
    Date of Event
    September 25, 2004
    Report Date
    October 29, 2004
    Manufacturer
    HUDSON RCI
    Product Code
    BTT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2004, FACILITY REPORTED THAT THERE HAD BEEN A PT DEATH IN 04, AND THE HUDSON RCI 003-40, AQUAPAK HUMIDIFIER BOTTLE, WAS ALLEGEDLY IMPLICATED. DURING THE ROUTINE WEEKLY CHANGING OF THE OXYGEN TUBING AND HUMIDIFIER BOTTLES BY THE FACILITY, A TERMINALLY ILL PT WAS FOUND DEAD IN THEIR ROOM. THE HOSP STATED THAT THEIR EXAMINATION OF THE EQUIPMENT CONCLUDED THAT THE TRIGGER PORT WAS NOT LARGE ENOUGH TO ALLOW THE PT TO GET PROPER OXYGEN, AND THE WINGNUT AND ADAPTER TO BOTTLE CONNECTIONS WERE LOOSE. FACILITY REPORTED THAT THE OXYGEN FLOW RATE AT THE TIME OF THE INCIDENT WAS 2 LPM AND THE DR'S ORDERS STATED TO ADMINISTER 2 LPM OR GREATER TO MAINTAIN AN OXYGEN SATURATION OF 94%. FACILITY FURTHER REPORTED THAT THE PT OXYGEN SATURATION WAS NOT MONITORED 24 HOURS A DAY. THE CUSTOMER DID MENTION THAT THE BOTTLE WAS BUBBLING. THE CAUSE OF DEATH HAS NOT BEEN DISCLOSED, THE ACTUAL SAMPLE HAS NOT BEEN RECEIVED, AND NO ADDITIONAL INFO ON THE EVENTS LEADING TO THE DEATH HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AQUA PAK HUMIDIFIER PREFILLED HUMIDIFIER BTT HUDSON RCI NA 418147

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death