BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2435427 · Received February 1, 2012

    Report

    Report Number
    9611451-2012-00048
    Event Type
    Malfunction
    Date Received
    February 1, 2012
    Date of Event
    January 1, 2012
    Report Date
    January 5, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290V CHAMBER WAS VISUALLY INSPECTED. RESULTS: THE WATER FEEDSET TUBE WAS FOUND CUT AT THE CONNECTION TO THE CHAMBER. THE SURFACE OF THE CUT WAS ROUGH. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110726. CONCLUSION: THE WATER FEEDSET TUBE OF THE COMPLAINT CHAMBER WAS CUT. THE CUT WAS ROUGH SUGGESTING THAT THE DAMAGE MAY HAVE OCCURRED AS A RESULT OF THE TUBE BEING PULLED AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSET TUBE 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. IT IS AN AUTOMATED PROCESS AND THE COMPLAINT CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT THE WATER FEEDSET WAS DAMAGED POST-PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARMS." "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 HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT THE WATER FEEDSET TUBE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS CUT NEAR THE CHAMBER DOME, CAUSING THE WATER TO LEAK. THIS WAS NOTICED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 110726

    Patients

    Seq Age Sex Outcome Treatment
    1