BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1762781 · Received June 25, 2010

    Report

    Report Number
    9611451-2010-00375
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Date of Event
    May 10, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE MR290 WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: A SPLIT WAS FOUND IN THE MR290 FEED SET TUBING. THE SURFACE OF THE SPLIT HAS ROUGH EDGES. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 091118. CONCLUSION: THE SURFACE OF THE SPLIT IN THE FEED SET TUBING WAS ROUGH, SUGGESTING THAT THE SPLIT WAS CAUSED BY PULLING. ALL MR290 CHAMBERS ARE PRESSURE TESTED FOR LEAKS BEFORE THEY LEAVE THE PRODUCTION LINE. THIS SUGGESTS THAT THE FEED SET TUBING WAS SPLIT POST-PRODUCTION. IT IS LIKELY THAT THE TUBING HAD A SHORT TAIL LENGTH, CAUSING TENSION WHEN THE TUBING WAS WOUND FOR SHIPPING AND EVENTUALLY CAUSING THE FEED SET TUBING TO SPLIT. 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 PT." (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED THAT AN MR20 AUTOFEED HUMIDIFICATION CHAMBER WAS LEAKING. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290V 091118

    Patients

    Seq Age Sex Outcome Treatment
    1