BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2060472 · Received April 17, 2011

    Report

    Report Number
    9611451-2011-00242
    Event Type
    Malfunction
    Date Received
    April 17, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 21, 2011
    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 NOT RETURNED FOR EVALUATION. HOWEVER, TWO UNUSED CHAMBERS FROM THE SAME LOT NUMBER 110301 WERE RETURNED. THE RETURNED CHAMBERS WERE VISUALLY INSPECTED AND PERFORMANCE TESTED BY ATTACHING TO A WATER BOTTLE. RESULTS: NO DAMAGES WERE OBSERVED ON THE RETURNED CHAMBERS. WHEN CONNECTED TO THE WATER BOTTLE, WATER FLOWED INTO THE CHAMBERS NORMALLY. THE CHAMBERS FILLED SUCCESSFULLY AND STOPPED AT THE MAXIMUM LINE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE MR290 IS A SINGLE USE AUTOFEED HUMIDIFICATION CHAMBER USED TO MAINTAIN CONSTANT HUMIDITY LEVEL FOR THE PATIENT. IT HAS A UNIQUE DUAL FLOAT MECHANISM THAT USES INDEPENDENT FLOATS TO CONTROL THE AMOUNT OF WATER WHICH FLOWS INTO THE CHAMBER AND TO SAFELY MAINTAIN A CONSTANT WATER LEVEL INSIDE THE CHAMBER FOR OPTIMAL HUMIDIFICATION. UNDER NORMAL CIRCUMSTANCES, THE BLUE "PRIMARY" FLOAT CONTROLS THE WATER LEVEL IN THE CHAMBER AND THE WHITE "SECONDARY" FLOAT ACTS AS A BACKUP TO PREVENT OVERFILLING IF THE PRIMARY FLOAT FAILS TO OPERATE. WE WERE UNABLE TO REPLICATE THE REPORTED FAULT WITH THE TWO RETURNED UNUSED MR290V HUMIDIFICATION CHAMBERS. WITHOUT A RETURN OF THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE CUSTOMER. THE MR290 USER INSTRUCTIONS ILLUSTRATE THAT THE WATER SOURCE (BAG OR BOTTLE) MUST BE MOUNTED A MINIMUM OF 50 CENTIMETERS ABOVE THE CHAMBER TO ENSURE PROPER WATER FLOW. IT ALSO ADVISE THAT THE FILTER CAP MUST BE OPENED IF A WATER BAG OR BOTTLE IS USED. THE USER INSTRUCTIONS ALSO STATE "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER DID NOT FILL WITH WATER WHEN CONNECTED TO A WATERBAG DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 110301

    Patients

    Seq Age Sex Outcome Treatment
    1