BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 4022298 · Received August 19, 2014

    Report

    Report Number
    9611451-2014-00720
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    August 11, 2014
    Report Date
    August 11, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4). THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE DISTRIBUTOR AND OUR KNOWLEDGE OF THE PRODUCT. THE DISTRIBUTOR REPORTED THAT THE MR290 CHAMBER WATER FEEDSET WAS LEAKING AT THE CONNECTION TO THE CHAMBER DOME. WITHOUT THE RETURN OF THE COMPLAINT DEVICES WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM EXPERIENCED BY THE CUSTOMER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140211. THE DAMAGE APPEARS TO HAVE BEEN CAUSED BY THE FEEDSET TUBING BEING PULLED AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR PUT UNDER TENSION. WE HAVE CONDUCTED EXTENSIVE TESTING OF THE MR290 CHAMBER, WITH PARTICULAR EMPHASIS ON FEEDSET BREAKS. SIGNIFICANTLY WE HAVE NOT BEEN ABLE TO REPLICATE FAILURE OF THE FEEDSET TUBE AT THE CHAMBER DOME IN ANY OF OUR TESTING. THE SPECIFICATION FOR THE CHAMBER REQUIRES THAT THE FEEDSET TUBE SHOULD HAVE A BREAKING STRAIN OF 30 NEWTONS. DURING PRODUCTION, PULL TESTING OF THE FEEDSET STRENGTH AT BOTH SPIKE AND DOME END IS PERFORMED EVERY HOUR ON MR290 CHAMBERS FROM EACH PRODUCTION LINE. IF ANY FAULTS ARE DETECTED 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 PROBLEM OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER 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 DISTRIBUTOR IN (B)(6) REPORTED THAT THE WATER FEEDSET OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER STARTED TO LEAK AT THE CHAMBER DOME CONNECTION. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499177 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 140211

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE RT212 BREATHING CIRCUIT