BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1668631 · Received April 21, 2010

    Report

    Report Number
    9611451-2010-00241
    Event Type
    Malfunction
    Date Received
    April 21, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 30, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT CHAMBER WAS VISUALLY EXAMINED THEN CONNECTED TO A WATER BAG TO TEST FOR OVERFILLING. RESULTS: THERE WAS NO VISIBLE DAMAGE TO THE CHAMBER. WHEN THE CHAMBER WAS CONNECTED TO A WATER BAG, THE FLOATS OPERATED NORMALLY AND THE CHAMBER STOPPED FILLING BELOW THE MAXIMUM FILL LINE. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 090921. CONCLUSION: IT IS POSSIBLE THAT THE FLOATS JAMMED DURING USE BUT REALIGNED DURING TRANSPORT BACK TO (B)(4). THE MR290 CHAMBER CONSISTS OF A DUAL FLOAT MECHANISM UTILIZING INDEPENDENT FLOATS TO CONTROL THE AMOUNT OF WATER FLOWING INTO THE CHAMBER. THE FLOAT MECHANISM OF EVERY MR290 CHAMBER IS RIGOROUSLY PERFORMANCE TESTED AND THOSE THAT FAIL ARE REJECTED. THE MR290 USER INSTRUCTIONS STATE THE FOLLOWING: "DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED" AND "DO NOT USE THE CHAMBER IF THE WATER LEVEL RISES ABOVE THE MAXIMUM. (B)(4).

    Description of Event or Problem · 1

    A HEALTH CARE COMPANY IN (B)(6) REPORTED THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER OVERFILLED BEFORE USE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290 090921

    Patients

    Seq Age Sex Outcome Treatment
    1