BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2232099 · Received September 1, 2011

    Report

    Report Number
    9611451-2011-00538
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE HAVE RECENTLY RECEIVED THE COMPLAINT DEVICE AND HAVE NOT BEGUN THE INVESTIGATION PROCESS. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE CONNECTION BETWEEN THE CHAMBER AND THE WATER FEEDSET TUBING WAS BROKEN. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101006. CONCLUSION: THE FEEDSET TUBE ON THE RETURNED MR290V CHAMBER WAS FOUND BROKEN. THE BREAK WAS ROUGH, SUGGESTING THAT THE DAMAGE MAY HAVE OCCURRED AS A RESULT OF THE FEEDSET TUBE BEING PULLED AWAY FROM THE DOME, POSSIBLY DUE TO BEING CAUGHT OR UNDER TENSION. AS PART OF OUR MANUFACTURING PROCESS, EVERY MR290 CHAMBER UNDERGOES PRESSURE TESTING FOR POTENTIAL LEAKS AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE FEEDSET WAS DAMAGED 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." "SET APPROPRIATE VENTILATOR ALARM." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A TEAR WAS FOUND BETWEEN THE WATER FEEDSET TUBE AND THE DOME OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED THAT A TEAR WAS FOUND BETWEEN THE WATER FEEDSET TUBE AND THE DOME OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 101006

    Patients

    Seq Age Sex Outcome Treatment
    1