BEUDAMED
    FDA Adverse Event Summary report: N

    HUMIDIFIER, RESPIRATORY GAS

    MDR report key: 3131178 · Received June 18, 2008

    Report

    Report Number
    9611451-2008-00364
    Date Received
    June 18, 2008
    Date of Event
    May 10, 2008
    Report Date
    May 20, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K953392
    Product Problem
    Yes
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE HC500 WAS FORWARDED TO OUR UNITED STATES OFFICE WHERE CALIBRATION AND PERFORMANCE TESTS WERE PERFORMED. RESULTS: INITIALLY THE TEMPERATURE PROBE SOCKET HAD TO BE REPAIRED PRIOR TO OPERATION OF THE HC500. THIS FAULT, HOWEVER, HAS BEEN ASCERTAINED NOT TO PLAY A CONTRIBUTING FACTOR TO THIS INCIDENT. SUBSEQUENTLY, THE DEVICE PASSED ALL CALIBRATION AND FUNCTIONAL TESTS. CONCLUSIONS: THE RESULTS INDICATE THAT THE HC500 HUMIDIFIER IS OPERATING CORRECTLY. THE MELTING OF THE CIRCUIT IS MOST LIKELY CAUSED BY OVERHEATING OF THE CIRCUIT AS A DIRECT RESULT OF THE PILLOW PREVENTING ADEQUATE VENTILATION OF THE SYSTEM. THE USER INSTRUCTIONS CAUTION AGAINST COVERING "THE PT DELIVERY TUBE WITH BLANKETS, TOWELS OR SIMILAR MATERIAL AS THIS MAY CAUSE THE PT DELIVERY TUBE TO OVERHEAT."

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HUMIDIFIER, RESPIRATORY GAS 73 BTT BTT FISHER & PAYKEL HEALTHCARE, LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1