BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3953705 · Received July 23, 2014

    Report

    Report Number
    9611451-2014-00647
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 21, 2014
    Report Date
    June 27, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION AND WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE. RESULTS: VISUAL INSPECTION REVEALED THAT THE COMPLAINT CHAMBER WAS CRACKED NEAR THE BASE AT THE HINGE BRACKET AND BELOW ONE OF THE PORTS. THE PRINTING ON THE CHAMBER DOME WAS SMEARED IN THE VICINITY OF THE CRACK AND FLOW MARKS AND RESIDUE WERE ALSO PRESENT. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 140205. CONCLUSION: THE NATURE OF THE CRACKING AND THE SMEARED PRINT ON THE CHAMBER DOME 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." THE HOSPITAL REPORTED THAT IT WAS POSSIBLE THAT THE CHAMBER WAS CLEANED OR HAD COME INTO CONTACT WITH A CLEANING SOLUTION, WHICH IS NOT IN LINE WITH OUR USER INSTRUCTIONS. 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. THIS SUGGESTS THAT THE CRACKING OCCURRED AFTER THE PRODUCT WAS RELEASED FOR DISTRIBUTION. 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 VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS LEAKING FROM THE CHAMBER DOME. NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432362 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 140205

    Patients

    Seq Age Sex Outcome Treatment
    1