BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3169082 · Received June 13, 2013

    Report

    Report Number
    9611451-2013-00472
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Report Date
    May 16, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS, ONE FROM LOT 120914 AND ONE FROM LOT 121001(DATE MANUFACTURED: 01 OCTOBER 2012), WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION. THE BASE THICKNESS OF EACH CHAMBER WAS MEASURED TO CHECK WHETHER IT WAS WITHIN SPECIFICATION. RESULTS: THE BASE THICKNESS OF BOTH OF THE RETURNED MR290 CHAMBERS WAS OUT OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 120914 & 121001. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE DAMAGE OBSERVED ON THE RETURNED MR290 CHAMBERS. HOWEVER IT IS POSSIBLE THAT PRESSURES GREATER THAN 8KPA IN THE CHAMBER CAN CAUSE THIS TYPE OF DAMAGE TO THE CHAMBER BASE AND DOME CONNECTION AND THE BASE THICKNESS TO BECOME OUT OF SPECIFICATION. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THE SUBJECT MR290V CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION PRIOR TO BEING RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290 STATE THE FOLLOWING: "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE [8KPA (~80CMH2O)] MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS COULD LEAD TO A LOSS OF VENTILATION PRESSURE". "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSION BEFORE CONNECTING TO A PATIENT".

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING WATER DURING USE. THEY FURTHER REPORTED THAT THIS HAS OCCURRED BEFORE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN DENMARK REPORTED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT THE MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING WATER DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268345 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120914

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH RT203 ADULT BREATHING CIRCUIT