BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1706953 · Received May 25, 2010

    Report

    Report Number
    9611451-2010-00297
    Event Type
    Malfunction
    Date Received
    May 25, 2010
    Report Date
    April 28, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 THAT PRODUCT IS K033710. METHOD: THE HC550 RESPIRATORY HUMIDIFIER, 900MR559 AND 900MR859 HEATER WIRE ADAPTORS, AND 900MR869 TEMPERATURE PROBES WERE PERFORMANCE TESTED BY FISHER & PAYKEL HEALTHCARE'S SERVICE CENTRE IN (B)(4). (B)(6) STATED THAT THE CIRCUITS COULD NOT BE RETURNED AS THEY HAD BEEN SCRAPPED. SHE CONFIRMED THAT THEY WERE MEDICARE CIRCUITS BUT DID NOT KNOW WHICH MODEL. RESULTS: NO FUNCTIONAL FAULTS WERE FOUND WITH THE HC550 RESPIRATORY HUMIDIFIER, THE TEMPERATURE PROBES OR THE HEATER WIRE ADAPTORS AS THEY OPERATED PROPERLY DURING TESTING. THE DEVICES WERE RETURNED TO THE CUSTOMER, WHO CONTINUES TO USE THEM. CONCLUSION: THE FISHER & PAYKEL HEALTHCARE RESPIRATORY HUMIDIFIER AND ASSOCIATED ACCESSORIES WERE VERIFIED TO BE OPERATING PROPERLY DURING PERFORMANCE TESTING. THE HUMIDIFIER HAS BEEN RETURNED TO THE HOSPITAL AND HAS NOT BEEN ASSOCIATED WITH ANY FURTHER PRODUCT COMPLAINTS. THE BREATHING CIRCUIT WAS NOT MANUFACTURED BY FISHER & PAYKEL HEALTHCARE SO WE ARE UNABLE TO COMMENT ON THE PERFORMANCE OF THE CIRCUIT. THE HC550 USER INSTRUCTIONS ADVISE THE USER THAT "THE USE OF BREATHING CIRCUITS, CHAMBERS OR OTHER ACCESSORIES WHICH ARE NOT APPROVED BY FISHER & PAYKEL HEALTHCARE MAY IMPAIR PERFORMANCE OR COMPROMISE SAFETY."

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT AN HC550 RESPIRATORY HUMIDIFIER ALLEGEDLY OVERHEATED AND THAT THE BREATHING CIRCUIT "BECAME CHARRED AT THE ENDS." IT WAS ALSO REPORTED THAT THERE WAS NO PT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD. HC550 051026

    Patients

    Seq Age Sex Outcome Treatment
    1 900MR559| 900MR859 HEATER WIRE ADAPTORS.| FISHER & PAYKEL HEALTHCARE 900MR869| TEMPERATURE PROBES