BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2931963 · Received January 28, 2013

    Report

    Report Number
    9611451-2013-00064
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 10, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT CHAMBER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE COMPLAINT CHAMBER WAS CONNECTED TO A WATER BAG TO TEST FOR LEAKS. RESULTS: NO LEAK WAS OBSERVED WHEN THE WATERBAG WAS CONNECTED AND WATER FLOWED INTO THE CHAMBER NORMALLY. THE CHAMBER FILLED SUCCESSFULLY AND STOPPED AT THE MAXIMUM LINE. CONCLUSION: NO FAULT WAS FOUND WITH THE RETURNED CHAMBER. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARM." "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 THE WATER FEEDSET TUBE OF AN MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS "DAMAGED". THIS WAS REPORTED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38078 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290 120615

    Patients

    Seq Age Sex Outcome Treatment
    1