BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2033046 · Received March 29, 2011

    Report

    Report Number
    9611451-2011-00205
    Event Type
    Malfunction
    Date Received
    March 29, 2011
    Report Date
    March 1, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT CHAMBER WAS VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED THAT THERE WAS A BREAK IN BETWEEN THE FEEDSET TUBE AND WHERE IT IS INSERTED INTO THE VENT SPIKE. THE SURFACE OF THE BREAK IS ROUGH. A LOT CHECK REVEALED (B)(4) OTHER SIMILAR COMPLAINT OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE SURFACE OF THE BREAK IS ROUGH, SUGGESTING THAT THE TUBING WAS BROKEN BY STRETCHING, PLACED UNDER TENSION OR PULLING RATHER THAN CUTTING. 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 UNCLEAR WHETHER THE TUBING MAY HAVE SUSTAINED DAMAGE PRIOR TO FORCE BEING APPLIED TO THE TUBING. ANY PREVIOUSLY SUSTAINED DAMAGE WOULD HAVE MADE THE TUBING MORE SUSCEPTIBLE TO BREAKING IF THE TUBING WAS PULLED. 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". OUR MONITORING AND TRENDING OF LEAKING MR290 FEED SET TUBING HAS A RATE OF OCCURRENCE OF (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS WATER LEAKAGE FROM THE WATER FEEDSET OF THE MR290V AUTOFEED HUMIDIFICATION CHAMBERS. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THERE WAS WATER LEAKAGE FROM THE WATER FEEDSET OF THE MR290V AUTOFEED HUMIDIFICATION CHAMBERS. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 100216

    Patients

    Seq Age Sex Outcome Treatment
    1