BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1695656 · Received May 17, 2010

    Report

    Report Number
    9611451-2010-00282
    Event Type
    Malfunction
    Date Received
    May 17, 2010
    Report Date
    April 21, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. THE HC550 RESPIRATORY HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) OFFICE IN (B)(4) FOR INVESTIGATION. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION TO ASSIST US WITH THE ANALYSIS OF THE EVENT. WE WILL PROVIDE A FOLLOW UP REPORT WITH THE RESULTS OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED VIA A DISTRIBUTOR IN (B)(6) THAT THERE WAS EXCESS CONDENSATION IN AN RT443 ADULT BREATHING CIRCUIT DURING USE ON A PATIENT. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE, LTD. HC550 070510

    Patients

    Seq Age Sex Outcome Treatment
    1 RESMED VS III VENTILATOR| FISHER AND PAYKEL HEALTHCARE RT443 ADULT BREATHING| CIRCUIT