BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2020762 · Received March 16, 2011

    Report

    Report Number
    9611451-2011-00163
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    February 18, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 RETURNED MR290 CHAMBER WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: A SMALL BREAK WAS OBSERVED IN THE FEEDSET TUBING AT THE CONNECTION TO THE WATERBAG SPIKE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100508. CONCLUSION: THE DAMAGE APPEARS TO BE DUE TO THE TUBE BEING PULLED AWAY FROM THE SPIKE, POSSIBLY IF THE SPIKE GOT CAUGHT OR WAS UNDER TENSION. ALL MR290 CHAMBERS ARE PRESSURE TESTED FOR LEAKS BEFORE THEY LEAVE THE PRODUCTION LINE. A SPLIT IN THE TUBING WOULD HAVE CAUSED THE DEVICE TO FAIL PRESSURE TESTING; THIS SUGGESTS THAT THE FEED SET TUBING WAS SPLIT POST-PRODUCTION. THE MR290 USER INSTRUCTIONS STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT". (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT WATER FEEDSET TUBING OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER LEAKED. 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 100508

    Patients

    Seq Age Sex Outcome Treatment
    1