BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2554174 · Received April 30, 2012

    Report

    Report Number
    9611451-2012-00270
    Event Type
    Malfunction
    Date Received
    April 30, 2012
    Date of Event
    March 30, 2012
    Report Date
    April 2, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT DEVICES, ONE FROM LOT 111018 AND ONE FROM LOT 111008, WERE VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED A BREAK AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND THE CHAMBER DOME IN BOTH DEVICES. THE SURFACE AT THE BREAK WAS ROUGH. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR EITHER LOT NUMBER. 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. 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 CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT THE WATER FEEDSETS WERE 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).

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT MR290 CHAMBER FROM THE HOSPITAL. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A WATER LEAK OCCURRED WHEN AN MR290 HUMIDIFICATION CHAMBER WAS CONNECTED TO A WATER BAG. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE A WATER LEAK OCCURRED WHEN THE MR290 CHAMBER WAS CONNECTED TO A WATER BAG. 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 111018

    Patients

    Seq Age Sex Outcome Treatment
    1