BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1891481 · Received November 4, 2010

    Report

    Report Number
    9611451-2010-00672
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 22, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT CHAMBER AND ASSOCIATED FEEDSET TUBING WERE VISUALLY INSPECTED FOR DAMAGE. RESULTS: A SMALL SPLIT WAS FOUND IN THE FEEDSET TUBING WHERE IT ATTACHES TO THE SPIKE. THE SURFACE OF THE SPLIT IS WAS ROUGH. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100127. CONCLUSION: THE SURFACE OF THE SPLIT TUBING WAS ROUGH, NOT SMOOTH. THIS SUGGESTS THAT THE TUBING HAD BEEN PULLED AWAY FROM THE DOME, POSSIBLY DUE TO THE FEEDSET BEING STRETCHED DURING THE WINDING PROCESS. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. OUR USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." OUR MONITORING AND TRENDING OF MR290 FEEDSET TUBING LEAKS HAS A RATE OF OCCURRENCE OF (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT WATER LEAKED FROM BETWEEN THE BAG SPIKE AND WATER FEED TUBE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT WATER LEAKED FROM BETWEEN THE BAG SPIKE AND WATER FEED TUBE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100127

    Patients

    Seq Age Sex Outcome Treatment
    1