BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2763669 · Received September 27, 2012

    Report

    Report Number
    9611451-2012-00663
    Event Type
    Malfunction
    Date Received
    September 27, 2012
    Date of Event
    August 21, 2012
    Report Date
    August 29, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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 COMPLAINT MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED A BREAK AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND THE CHAMBER DOME. THE SURFACE AT THE BREAK WAS ROUGH. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 110914. CONCLUSION: THE FEEDSET TUBE BREAK WAS ROUGH, SUGGESTING THAT THE DAMAGE MAY HAVE OCCURRED AS A RESULT OF THE TUBE BEING PULLED AWAY FROM THE DOME POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION, RATHER THAN BEING CUT. THE HOSPITAL CONFIRMED THAT THERE IS A POSSIBLITY THAT THE FEEDSET TUBE HAD BEEN CAUGHT UNDER TENSION. AS PART OF OUR MANUFACTURING PROCESS, EVERY MR290 CHAMBER UNDERGOES PRESSURE TESTING FOR POTENTIAL LEAKS AND THOSE THAT FAIL ARE REJECTED. THE COMPLAINT CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. A PULL TEST ON THE FEEDSET STRENGTH IS ALSO PERFORMED EVERY HALF HOUR ON MR290 CHAMBERS COMING OFF THE PRODUCTION LINE. SINCE THIS TESTING BEGAN IN 2008, WE HAVE HAD A ZERO DEFECT RATE. 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 REPRESENTATIVE THAT A WATER LEAK OCCURED FROM THE CONNECTION BETWEEN THE CHAMBER DOME AND WATER FEEDSET TUBE. THEY FURTHER REPORTED THAT THE WATER FEEDSET TUBE WAS TORN. THIS WAS FOUND DURING SETUP 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 110914

    Patients

    Seq Age Sex Outcome Treatment
    1