BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1739706 · Received June 10, 2010

    Report

    Report Number
    9611451-2010-00361
    Event Type
    Malfunction
    Date Received
    June 10, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 11, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290V CHAMBER WAS CONNECTED TO A WATER BAG TO TEST FOR FLOAT OPERATION AND OVERFILLING. RESULTS: THE FLOATS FUNCTIONED CORRECTLY AND CONTROLLED THE ENTRY OF WATER INTO THE CHAMBER. NO OVERFILLING OF THE CHAMBER OCCURRED. A LOT CHECK REVEALED NO OTHER COMPLAINT OF THIS NATURE FOR LOT # 100319. CONCLUSION: THE MR290 CHAMBER CONSISTS OF A DUAL FLOAT MECHANISM UTILIZING INDEPENDENT FLOATS TO CONTROL THE AMOUNT OF WATER FLOWING INTO THE CHAMBER. WE COULD NOT CONCLUDE HOW THE REPORTED OVER FILLING OF THE CHAMBER OCCURRED. THE RETURNED CHAMBER OPERATED CORRECTLY. FOLLOWING PRODUCTION, THE FLOAT MECHANISM OF EVERY MR290 CHAMBER ARE PERFORMANCE TESTED AND THOSE THAT FAIL THE TEST ARE REJECTED. FISHER & PAYKEL HEALTHCARE'S USER INSTRUCTIONS THAT ACCOMPANY THE MR290 CHAMBER INDICATE IN PICTORIAL FORM THE MAXIMUM FILL LINE AND ADVISES THE USER TO REPLACE THE CHAMBER SHOULD WATER EXCEED THE LIMIT LINE. (B)(4).

    Description of Event or Problem · 1

    A HOSP IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REP THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER OVERFILLED. THIS WAS NOTICED PRIOR TO PT CONNECTION AND NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290V 100319

    Patients

    Seq Age Sex Outcome Treatment
    1