BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2832498 · Received November 14, 2012

    Report

    Report Number
    9611451-2012-00822
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Report Date
    October 16, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT CHAMBER WAS NOT RETURNED FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE DESCRIPTION OF EVENTS AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: BASED ON PREVIOUS COMPLAINTS OF THIS NATURE THAT WE HAVE RECEIVED, THE LEAK WAS MOST LIKELY DUE TO A BREAK AT THE CONNECTION BETWEEN THE WATER FEEDSET TUBE AND THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: RESULTS OF PREVIOUS INVESTIGATIONS INTO THIS ISSUE HAVE SUGGESTED THAT THE DAMAGE MAY HAVE OCCURRED AS A RESULT OF THE TUBE BEING PULLED AWAY FROM THE DOME POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR UNDER TENSION. AS PART OF OUR MANUFACTURING PROCESS, EVERY MR290 CHAMBER UNDERGOES PRESSURE TESTING FOR POTENTIAL LEAKS AND THOSE THAT FAIL ARE REJECTED. IT IS AN AUTOMATED PROCESS AND THE COMPLAINT CHAMBER WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THIS SUGGESTS THAT THE WATER FEEDSET WAS DAMAGED POST-PRODUCTION. 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." (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT AN MR290 HUMIDIFICATION CHAMBER LEAKED BETWEEN THE WATER FEEDSET AND THE CHAMBER DOME. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1201210304

    Patients

    Seq Age Sex Outcome Treatment
    1