BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 2152912 · Received July 7, 2011

    Report

    Report Number
    9611451-2011-00410
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Report Date
    June 15, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    REFER TO H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LU
    Reporter Occupation
    NURSE

    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 (B)(4). THE COMPLAINT HC550 RESPIRATORY HUMIDIFIER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. AN ATTEMPT WAS ALSO MADE TO OBTAIN FURTHER INFORMATION REGARDING THE REPORTED FAULT; HOWEVER, NO REPLY WAS RECEIVED FROM THE HOSPITAL. WITHOUT THE COMPLAINT DEVICE OR ADDITIONAL INFORMATION FROM THE HOSPITAL, WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED FAULT. 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 (E.G. AIR CONDITIONING).

    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. THE HC550 RESPIRATORY HUMIDIFIER IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN HC550AFU RESPIRATORY HUMIDIFIER WAS DEFECTIVE. THE TEMPERATURE AT THE END OF THE CHAMBER WAS ABOUT 39°C AND THE PROXIMAL TEMPERATURE WAS 40°C. IT WAS FURTHER REPORTED THAT THERE WAS CONDENSATION IN THE BREATHING CIRCUIT BUT THE HUMIDIFIER DID NOT GIVE AN ALARM. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN HC550AFU RESPIRATORY HUMIDIFIER WAS DEFECTIVE. THE TEMPERATURE AT THE END OF THE CHAMBER WAS ABOUT 39 DEGREES C AND THE PROXIMAL TEMPERATURE WAS 40 DEGREES C. IT WAS FURTHER REPORTED THAT THERE WAS CONDENSATION IN THE BREATHING CIRCUIT BUT THE HUMIDIFIER DID NOT GIVE AN ALARM. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED HC550AFU

    Patients

    Seq Age Sex Outcome Treatment
    1