BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3041932 · Received April 8, 2013

    Report

    Report Number
    9611451-2013-00242
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 11, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    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)/. LOT NUMBERS AND MANUFACTURING DATES: 120112 - 12 JANUARY 2012. 120606 - 6 JUNE 2012. METHOD: THE TWO MR290 WATER CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR VISUAL INSPECTION. RESULTS: VISUAL INSPECTION REVEALED THAT THERE WAS A BREAK IN THE FEEDSET TUBE OF BOTH COMPLAINT CHAMBERS, WHERE THE TUBE IS INSERTED INTO THE CHAMBER. THE SURFACE AT THE BREAKS WAS ROUGH, AND NOT SMOOTHLY CUT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT NUMBERS 120112 AND 120606. CONCLUSION: THE DAMAGE ON THE FEEDSET TUBE APPEAR TO HAVE BEEN CAUSED BY THE TUBE BEING PULLED, AWAY FROM THE CHAMBER, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE; AND ANY HOLES, LEAKS, OR BREAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THIS SUGGESTS THAT THE DAMAGE OCCURRED POST PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARM." "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) INITIALLY REPORTED VIA A DISTRIBUTOR THAT THE HEATER WIRE PINS OF AN (B)(4) ADULT BREATHING CIRCUIT WERE DAMAGED. THE CUSTOMER ALSO RETURNED TWO MR290 WATER CHAMBERS TO FISHER & PAYKEL HEALTHCARE AND THEY WERE FOUND TO BE DAMAGED DURING OUR INVESTIGATION. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143097 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1