BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 988724 · Received January 31, 2008

    Report

    Report Number
    9611451-2008-00039
    Event Type
    Malfunction
    Date Received
    January 31, 2008
    Report Date
    January 2, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS PREPARED BY REP: ANALYSIS OF EVENT DESCRIPTION. RESULTS: THE MR850 HUMIDIFIER IS NOT DESIGNED FOR MONITORING AND ALARMING OF LEAKS IN THE BREATHING TUBING. IT IS DESIGNED TO MONITOR FOR OVER TEMPERATURES OF GAS DELIVERED TO THE PT ONLY AND ALARM ACCORDINGLY. THE VENTILATOR, THAT CONTROLS THE GAS FLOW, ALARMS IF THERE IS A SIGNIFICANT DROP IN PRESSURE FROM A HOLE IN THE TUBE OR OTHER LEAK. CONCLUSION: THERE IS NOTHING TO SUGGEST THE DEVICE WAS DEFICIENT FROM THE EVENT DESCRIPTION. WITHOUT THE DEVICE TO INVESTIGATE NO CONCLUSION CAN BE MADE AS TO THE PERFORMANCE OF THE HUMIDIFIER. IT IS LIKELY THAT THE MALFUNCTION HAS OCCURRED IN THE BREATHING TUBE TO CAUSE THE HOLE IN THE TUBE.

    Description of Event or Problem · 1

    A HOSP VIA CARDINAL HEALTH WANTED TO KNOW WHY THE MR850 HUMIDIFIER DID NOT ALARM WHEN THE BREATHING CIRCUIT HEATER WIRE MADE A HOLE IN THE CIRCUIT TUBING. THE BREATHING CIRCUIT IS MFG BY CARDINAL HEALTH, MODEL AIRLIFE RT509 852.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD MR850

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH 900MR800 HEATER WIRE ADAPTER| CARDINAL HEALTH BREATHING CIRCUIT| FPH 900MR869 TEMPERATURE/FLOW PROBE| MODEL AIRLIFE RO509-852