BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3911148 · Received July 2, 2014

    Report

    Report Number
    9611451-2014-00586
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    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 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED.RESULTS: VISUAL INSPECTION REVEALED A BREAK IN THE FEEDSET TUBING AT THE CONNECTION TO THE CHAMBER DOME. THE SURFACE AT THE BREAK WAS ROUGH. THE DAMAGE APPEARED TO BE DUE TO THE TUBE BEING PULLED AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR PUT UNDER TENSION.A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 131012.CONCLUSION: WE WERE UNABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THE FEEDSET BREAK, HOWEVER OUR PREVIOUS INVESTIGATIONS INTO SIMILAR COMPLAINTS HAVE SHOWN THAT THIS DAMAGE CAN BE CAUSED BY THE OVERSTRETCHING OF THE TUBING WHEN ATTACHING IT TO A WATER BAG.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. THE CUSTOMER HAS CONFIRMED THAT THE SUBJECT CHAMBER WAS IN USE FOR ONE WEEK BEFORE A LEAK WAS OBSERVED, WHICH INDICATES THAT THE CHAMBER BECAME DAMAGED DURING USE.THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 AUTOFEED HUMIDIFICATION CHAMBERS 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 VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE WATER FEEDSET OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER STARTED TO LEAK AT THE CHAMBER DOME CONNECTION AFTER ONE WEEK OF USE.NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385987 VENTED AUTOFEED CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 131012

    Patients

    Seq Age Sex Outcome Treatment
    1