BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1957775 · Received January 11, 2011

    Report

    Report Number
    9611451-2011-00023
    Event Type
    Malfunction
    Date Received
    January 11, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 17, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED AUTOFILL HUMIDIFICATION CHAMBER WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: A BREAK WAS FOUND IN THE FEEDSET TUBE AT THE POINT WHERE THE TUBE IS INSERTED INTO THE SPIKE. THE SURFACE OF THE BREAK IS ROUGH. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 090802. CONCLUSION: THE SURFACE OF THE SPLIT IN THE FEED SET TUBING WAS ROUGH, SUGGESTING THAT THE SPLIT WAS CAUSED BY PULLING. IT IS POSSIBLE THAT THE SPIKE GOT CAUGHT OR THAT THE TUBING HAD BEEN UNDER TENSION, CAUSING THE TUBE TO BREAK. 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. THE INSTRUCTIONS PROVIDED WITH THE MR290 CHAMBERS ADVISE THE USER TO "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT". (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE WATERFEED TUBING BROKE OFF OF AN MR290 AUTOFILL HUMIDIFICATION CHAMBER. THE TUBING SEPARATED FROM THE CHAMBER PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE WATERFEED TUBING BROKE OFF OF AN MR290 AUTOFILL HUMIDIFICATION CHAMBER. THE TUBING SEPARATED FROM THE CHAMBER PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 090802

    Patients

    Seq Age Sex Outcome Treatment
    1