BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1719567 · Received May 31, 2010

    Report

    Report Number
    9611451-2010-00343
    Event Type
    Malfunction
    Date Received
    May 31, 2010
    Report Date
    May 3, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HC550 RESPIRATORY HUMIDIFIER IS NOT SOLD IN THE UNITED STATES, BUT IS SIMILAR TO A PRODUCT THAT IS SOLD IN THE UNITED STATES. THE 510 (K) NUMBER OF THE SIMILAR PRODUCT IS K033710. METHOD: THE COMPLAINT HC550 RESPIRATORY HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE'S OFFICE IN (B)(4) FOR TESTING. THE HUMIDIFIER WAS TESTED IN ACCORDANCE WITH THE PRODUCT TECHNICAL MANUAL. RESULTS: THE HC550 HUMIDIFIER FUNCTIONED PROPERLY DURING TESTING AND NO FAULT WAS FOUND WITH THE DEVICE. CONCLUSION: NO FAULT WAS FOUND WITH THE DEVICE AND THE REPORTED FAULT COULD NOT BE REPLICATED. CONDENSATE IN THE HUMIDIFICATION SYSTEM, ALTHOUGH NOT PREFERRED, IS AN EXPECTED SIDE EFFECT OF HEATED PASS-OVER HUMIDIFICATION SYSTEMS IN MANY CONDITIONS, AND MAY VARY BETWEEN LIGHT MISTING TO WATER DROPLETS THAT FORM ON THE WALL OF COOL BREATHING CIRCUIT TUBING. THE AMOUNT OF CONDENSATE IN THE VENTILATION SYSTEM IS INFLUENCED BY MULTIPLE SET-UP AND ENVIRONMENTAL FACTORS. ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION FROM THE CUSTOMER INCLUDING THE AMOUNT OF CONDENSATION OBSERVED IN THE SYSTEM TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE EVENT AS REPORTED, HOWEVER NO FURTHER INFORMATION HAS BEEN FORTHCOMING. WITHOUT FURTHER INFORMATION SURROUNDING THE ISSUE, WE DO NOT KNOW THE EXTENT OF THE CONDENSATION ISSUE EXPERIENCED AND EXACTLY WHAT CAUSED THE REPORTED INCIDENT. IT IS HOWEVER POSSIBLE THAT SET-UP AND ENVIRONMENTAL CONDITIONS MAY HAVE CONTRIBUTED TO THE CAUSE OF THE ISSUE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THERE WAS TOO MUCH CONDENSATION IN A BREATHING CIRCUIT. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD. HC550 060926

    Patients

    Seq Age Sex Outcome Treatment
    1