BEUDAMED
    FDA Adverse Event Other Summary report: N

    HUMIDIFIER EMPTY, 6 PSI BLUE

    MDR report key: 1172660 · Received September 15, 2008

    Report

    Report Number
    1423507-2008-00073
    Event Type
    Other
    Date Received
    September 15, 2008
    Date of Event
    August 15, 2008
    Report Date
    September 12, 2008
    Manufacturer
    CARDINAL HEALTH
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT REPORTED WAS EVALUATED FOR ANY ISSUES RELATED TO THIS CUSTOMER REPORT. THE PRODUCT WAS MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE WITH OUR INTERNAL PROCEDURES AND NO ISSUES WERE OBSERVED. THE PRODUCT SAMPLE RECEIVED FROM THE CUSTOMER WAS EVALUATED ACCORDING TO OUR INSPECTION PROCEDURE. THE PRESSURE TEST WAS PERFORMED AND WE OBSERVED THAT THE BRASS WEIGHT COMPONENT WAS MISSING; CONSEQUENTLY, OXYGEN COULD NOT FLOW THROUGH THE PRODUCT, AND THE REPORTED PROBLEM WAS CONFIRMED. BASED ON THIS INFO, IT APPEARS THIS WAS AN ISOLATED EVENT IN WHICH MFG PERSONNEL FAILED TO ASSEMBLE THIS PARTICULAR UNIT ACCORDING TO THE PROCEDURE. OUR OPERABLE PERSONNEL WILL BE RE-TRAINED IN ORDER TO PREVENT THIS KIND OF INCIDENT. OUR MFG PROCESS WAS REVIEWED AND NO PROBLEMS WERE FOUND RELATED TO THE ISSUE REPORTED. WE HAVE RECEIVED NO OTHER COMPLAINTS FOR THIS REPORTED ISSUE. THE DIRECTIONS FOR USE OF THE PRODUCT DO STATE, "TEST TO LEAKS AND PROPER FUNCTION OF PRESSURE RELIEF VALVE WHISTLE. APPLY GAS FLOW OF 3 L/MIN. OCCLUDE O2 PORT AND LISTEN FOR ALARM WHISTLE. IF ALARM DOES NOT ACTIVATE, CHECK ALL CONNECTIONS FOR POSSIBLE LEAKS."

    Description of Event or Problem · 1

    CUSTOMER REPORTED: "WHEN THE HUMIDIFIER WAS HOOKED UP TO THE OXYGEN, IT WOULD NOT ALLOW OXYGEN TO FLOW TO THE PT AND CAUSED THE PT TO GO INTO CARDIAC ARREST." CUSTOMER LATER INDICATED THAT PT WAS FOUND TO BE IN RESPIRATORY DISTRESS-NO ALARM SOUNDED-PULSE AT 58. PT PUT ON ANOTHER CONCENTRATOR, BOTTLE AND CANNULA AND SHE WENT UP TO 72, AND WAS SENT TO THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMIDIFIER EMPTY, 6 PSI BLUE EMPTY HUMIDIFIER BTT CARDINAL HEALTH 002006 Y07S0166

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention