BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3346367 · Received September 12, 2013

    Report

    Report Number
    9611451-2013-00691
    Event Type
    Malfunction
    Date Received
    September 12, 2013
    Date of Event
    July 29, 2013
    Report Date
    August 15, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS RECEIVED FOR EVALUATION AND WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT THE COMPLAINT CHAMBER WAS CRACKED BELOW ONE OF THE PORTS AND THE BRACKET, STRETCHING ALONG THE BASE. RESIDUE WAS FOUND IN SEVERAL PLACES ON THE OUTSIDE AND INSIDE OF THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 130224. CONCLUSION: THE NATURE OF THE CRACKING AND THE RESIDUE FOUND ON THE RETURNED COMPLAINT CHAMBER INDICATES THAT THE DAMAGE WAS CAUSED BY ENVIRONMENTAL STRESS CRACKING DUE TO THE CHAMBER DOME COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL. THE MR290 AUTOFEED HUMIDIFICATION CHAMBER IS A SINGLE USE DEVICE, MANUFACTURED IN A CLEAN WORKING ENVIRONMENT AND DOES NOT REQUIRE ANY CLEANING. TO THIS END OUR USER INSTRUCTIONS STATE: "DO NOT SOAK, WASH, STERILISE OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THE HOSPITAL HAD CONFIRMED THAT THE CHAMBER HAD BEEN IN USE FOR A DAY BEFORE THE CRACKING OCCURRED, INDICATING THAT IT WAS INITIALLY FUNCTIONING AS INTENDED. 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." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS LEAKING. THIS OCCURRED AFTER ONE DAY OF PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459994 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1302240304

    Patients

    Seq Age Sex Outcome Treatment
    1