BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2391094 · Received December 28, 2011

    Report

    Report Number
    9611451-2011-00831
    Event Type
    Malfunction
    Date Received
    December 28, 2011
    Report Date
    November 30, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) AND VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A BREAK AT THE FEEDSET TUBING WHERE IT IS INSERTED INTO THE SPIKE. THE SURFACE AT THE BREAK WAS ROUGH AND NOT SMOOTHLY CUT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 110413. 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. 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 THAT THE FEEDSET TUBE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER BROKE FREE FROM THE SPIKE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE FEEDSET TUBE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER BROKE FREE FROM THE SPIKE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1104130304

    Patients

    Seq Age Sex Outcome Treatment
    1