BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 5187716 · Received October 29, 2015

    Report

    Report Number
    9611451-2015-00454
    Event Type
    Malfunction
    Date Received
    October 29, 2015
    Date of Event
    September 28, 2015
    Report Date
    September 30, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: TWO OF THE THREE COMPLAINT MR290V AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF DEVICE 1 (LOT 150326) REVEALED A CRACK ABOVE THE BRACKET. RESIDUE AND RUN MARKS WERE ALSO OBSERVED NEXT TO THE BRACKET OF THE CHAMBER DOME. VISUAL INSPECTION OF DEVICE 2 (LOT 150413) REVEALED CRACKS ALONG THE BASE BELOW ONE PORT AND ALSO AT THE BAFFLE. RESIDUE WAS ALSO OBSERVED ABOVE THE CRACK RUNNING ALONG THE BASE, AT THE BAFFLE AND ALSO BELOW THE BRACKET. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBERS 150326 (MANUFACTURED 26 MARCH 2015) AND 150413 (MANUFACTURED 13 APRIL 2015). CONCLUSION:THE NATURE OF THE CRACKING AND RESIDUE SUGGEST THAT THE DAMAGE WAS CAUSED BY THE CHAMBERS COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL/ALCOHOL, WHICH HAS RESULTED IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOMES. IT IS ALSO POSSIBLE THAT THE PRESSURE FROM CPAP THERAPY CONTRIBUTED TO THE CRACKING OF THE CHAMBER DOME. 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 AN FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THREE MR290 HUMIDIFICATION CHAMBERS WERE FOUND CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719994 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 150326

    Patients

    Seq Age Sex Outcome Treatment
    1