BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3850069 · Received June 4, 2014

    Report

    Report Number
    9611451-2014-00487
    Event Type
    Malfunction
    Date Received
    June 4, 2014
    Date of Event
    April 25, 2014
    Report Date
    May 16, 2014
    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 AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE CHAMBER WAS VISUALLY INSPECTED AND ALSO CONNECTED TO A WATER BAG FOR PERFORMANCE TESTING. RESULTS: PERFORMANCE TESTING RESULTED IN A DROP OF WATER BUILDING AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND THE WATER BAG SPIKE. THERE WAS SUFFICIENT GLUE OBSERVED ON THE TUBING DURING VISUAL INSPECTION, HOWEVER IT WAS ONLY PARTLY BONDING. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 120718. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE REPORTED DAMAGE. HOWEVER THE DAMAGE APPEARS TO BE THE RESULT OF THE TUBE BEING PULLED INSTEAD OF THE SPIKE WHEN THE WATER BAG IS BEING CHANGED. WE HAVE CONDUCTED EXTENSIVE TESTING OF THE MR290 CHAMBER, WITH PARTICULAR EMPHASIS ON FEEDSET LEAKS. SIGNIFICANTLY WE HAVE NOT BEEN ABLE TO REPLICATE FAILURE OF THE FEEDSET TUBE IN ANY OF OUR TESTING. THE SPECIFICATION FOR THE CHAMBER REQUIRES THAT THE FEEDSET TUBE SHOULD HAVE A BREAKING STRAIN OF (B)(4). DURING PRODUCTION, PULL TESTING OF THE FEEDSET STRENGTH AT BOTH SPIKE AND DOME END IS PERFORMED (B)(4) ON MR290 CHAMBERS FROM EACH PRODUCTION LINE. IF ANY PRODUCT FAILS THIS TEST, THE WHOLE BATCH IS PLACED ON HOLD FOR INVESTIGATION. ADDITIONALLY ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. CHAMBERS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. THIS SUGGESTS THAT THE DAMAGE OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE CUSTOMER HAD CONFIRMED THAT IN ALL FOUR CASES THE FEEDSET TUBING HAD BECOME DAMAGED AFTER START OF USE. 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER AND PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT WATER LEAK OCCURRED AT THE CONNECTION OF THE WATER BAG SPIKE AND THE FEEDSET TUBE OF AN MR290 HUMIDIFICATION CHAMBER DURING PATIENT USE. THE INCIDENT OCCURRED AFTER TWO DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326743 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 120718

    Patients

    Seq Age Sex Outcome Treatment
    1