BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2305904 · Received October 24, 2011

    Report

    Report Number
    9611451-2011-00651
    Event Type
    Malfunction
    Date Received
    October 24, 2011
    Date of Event
    September 21, 2011
    Report Date
    September 29, 2011
    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 FOR DAMAGE. RESULTS: THE CHAMBER WAS FOUND BROKEN AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND CHAMBER DOME, CONFIRMING THE REPORTED FAULT. THE SURFACE OF THE BREAK WAS ROUGH. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110421 CONCLUSION: THE FEEDSET TUBE OF THE COMPLAINT CHAMBER WAS FOUND BROKEN. THE BREAK WAS ROUGH SUGGESTING THAT THE DAMAGE MAY HAVE OCCURRED AS A RESULT OF THE TUBE BEING PULLED AWAY FROM THE DOME, RATHER THAN BEING CUT. 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 FIELD REPRESENTATIVE THAT WATER LEAKED BETWEEN THE CONNECTION OF THE WATER FEEDSET TUBE AND CHAMBER DOME OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER. 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 110421

    Patients

    Seq Age Sex Outcome Treatment
    1