BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3675990 · Received March 12, 2014

    Report

    Report Number
    9611451-2014-00215
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    February 11, 2014
    Report Date
    February 14, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE WAS RECENTLY RECEIVED AT 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). CORRECTION: THE LOT DATE WAS INITIALLY REPORTED AS 130902 (2ND SEPTEMBER 2013). THIS HAS BEEN UPDATED TO 130806 (6TH AUGUST 2013) UPON THE RETURN OF THE DEVICE. METHOD: THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED A BREAK IN THE FEEDSET TUBE AT THE CONNECTION TO THE CHAMBER DOME. THE SURFACE AT THE BREAK WAS ROUGH (NOT SMOOTHLY CUT). A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 130806. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE REPORTED DAMAGE. HOWEVER THE DAMAGE APPEARS TO BE THE RESULT OF THE TUBE BEING PULLED AWAY FROM THE DOME, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR 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 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 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 VIA OUR DISTRIBUTOR THAT THE WATER FEEDSET TUBE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND BROKEN WHEN THEY OPENED THE CIRCUIT KIT. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE WATER FEEDSET TUBE OF AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND BROKEN WHEN THEY OPENED THE CIRCUIT KIT. THIS WAS OBSERVED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148956 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 130806

    Patients

    Seq Age Sex Outcome Treatment
    1