BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1565759 · Received December 18, 2009

    Report

    Report Number
    9611451-2009-00691
    Event Type
    Malfunction
    Date Received
    December 18, 2009
    Report Date
    November 20, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 AND ASSOCIATED 900MR869 TEMPERATURE PROBE HAVE BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE, (B)(4) FOR ANALYSIS. THE COMPONENTS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE LTD IN (B)(4). WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) RETURNED AN HC550 RESPIRATORY HUMIDIFIER FOR ANALYSIS BECAUSE, THEY WERE "NOT SURE IF THE DEVICE IS OVERHEATING OR THERE IS A PROBLEM WITH THE TEMPERATURE SENSOR." 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 060406

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE: 900MR869 TEMPERATURE| PROBE