BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 3588301 · Received January 22, 2014

    Report

    Report Number
    9611451-2014-00065
    Event Type
    Malfunction
    Date Received
    January 22, 2014
    Date of Event
    November 19, 2013
    Report Date
    November 20, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. FOUR DEVICES WERE RECEIVED, THREE OF LOT 130222 AND ONE OF LOT 130322. RESULTS: VISUAL INSPECTION REVEALED MULTIPLE CRACKS IN THE DEVICES, ALONG WITH FLOW MARKS, RESIDUE AROUND THE CHAMBER BASE, AND SMEARED PRINTING. DEVICE 1 PRESENTS A HORIZONTAL CRACK STRETCHING ALONG THE BASE, BELOW ONE OF THE CHAMBER PORTS. DEVICE 2 HAS MULTIPLE CRACKS RUNNING UPWARDS AROUND THE BASE AND TWO SMALL CRACKS ON THE DOME ABOVE THE HINGE BRACKET. DEVICE 3 HAS A CRACK IN THE DOME BELOW THE HINGE BRACKET WHICH STRETCHES ALONG THE BASE. TWO SMALLER CRACKS RUN ALONG THE BASE UNDER THE CHAMBER PORT. DEVICE 4 WAS CRACKED BELOW THE HINGE BRACKET AND ALONG THE BASE OF THE DOME. CONCLUSION: THE SMEARED PRINT, RESIDUE, AND FLOW MARKS ON THE DEVICES SUGGESTS THAT THE REPORTED DAMAGE WAS CAUSED BY THE CHAMBERS COMING INTO CONTACT WITH SOLUTIONS CONTAINING ETHANOL WHICH RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOMES. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOTS 130222 AND LOT 130322. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 200 CMH2O FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. SET APPROPRIATE VENTILATOR ALARMS. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. MAXIMUM OPERATING PRESSURE: 8 KPA.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN MR290V HUMIDIFICATION CHAMBER IS DEFECTIVE AND QUICKLY RUNS OUT OF WATER. THEY FURTHER COMMENTED THAT THIS HAS BEEN OBSERVED IN VARIOUS CHAMBERS OVER A SHORT PERIOD OF TIME. THIS OCCURRED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51944 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 130222

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL HEALTHCARE RT265 BREATHING CIRCUIT