BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1031119 · Received April 18, 2008

    Report

    Report Number
    9611451-2008-00173
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 28, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION, PHOTOS AND DISCUSSION WITH THE HOSPITAL. RESULTS: THE PHOTOS SHOW THE INSPIRATORY TUBE CONNECTED TO THE MR850 HUMIDIFIER BUT ON THE EXPIRATORY SIDE BACK TO THE VENTILATOR. NO HUMIDIFIED GAS WAS BEING APPLIED ON THE INSPIRATORY SIDE TO THE PT. UNHUMIDIFIED VENTILATOR GAS CAN LEAD TO DRYING OF THE PT'S RESPIRATORY TRACT AND THICKENING OF SECRETIONS OVER TIME. THE MR850 USER INSTRUCTIONS SHOW THE CORRECT SET UP OF THE BREATHING CIRCUITS TO THE VENTILATOR, AND THE INSPIRATORY AND EXPIRATORY TUBES ARE DIFFERENT COLORS. AN ALARM IS EXPECTED TO HAVE SOUNDED WHERE THE GAS FLOW IS REVERSED THROUGH THE HUMIDIFIER, BUT MAY NOT OCCUR DUE TO THE WRONG SET UP AND REVERSAL OF GAS FLOW THROUGH THE TUBE AND TEMPERATURE AND FLOW PROBES. CONCLUSIONS: THE HOSPITAL ASSUMED RESPONSIBILITY FOR WHAT HAD HAPPENED AND ATTRIBUTED THE EVENT TO INCORRECT SET UP. OUR FIELD REP IN ANOTHER COUNTRY CONDUCTED FURTHER TRAINING WITH THE HOSPITAL STAFF. THIS IS A VERY INFREQUENT OCCURRENCE.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED THAT THE INSPIRATORY AND EXPIRATORY TUBINGS OF MR850AFU RESPIRATORY HUMIDIFIER HAD BEEN SWAPPED AROUND FOR A FEW DAYS DURING THE VENTILATION OF THE PT. CONSEQUENTLY, THE INSPIRATORY TUBE DELIVERING HUMIDIFIED GAS WAS ON THE EXPIRATORY SIDE AND NO HUMIDIFICATION WAS PROVIDED FOR 4 TO 5 DAYS. THE HUMIDIFIER BASE CONTROLLER DISPLAYED A TEMPERATURE OF 39 DEGREES C BUT NO TEMPERATURE MONITORING WAS DONE AT THE Y-PIECE. THE RESPIRATORY HUMIDIFIER IS SUPPOSED TO GIVE AN ALARM WHEN THE DISPLAYED TEMPERATURE IS BEYOND THE GIVEN LIMITS, BUT IS DID NOT HAPPEN IN THAT SITUATION. THE HOSPITAL ASSUMED RESPONSIBILITY FOR WHAT HAD HAPPENED. THEY HAD PUT A NEW ENDOTRACHEAL TUBE TO THE PT AFTER THEY DID THE BRONCHOSCOPY TO REMOVE THICK SECRETIONS AND BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR850AFU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention