BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 5313053 · Received December 20, 2015

    Report

    Report Number
    9611451-2015-00547
    Event Type
    Malfunction
    Date Received
    December 20, 2015
    Date of Event
    November 24, 2015
    Report Date
    November 24, 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

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING THE COMPLAINT DEVICE FORM THE HOSPITAL. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4) METHOD: ONE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE RETURNED CHAMBER REVEALED A CRACK AROUND THE BASE OF THE CHAMBER DOME, BELOW THE BAFFLE. THE PRINTING ON THE DEVICE WAS ALSO OBSERVED TO BE SMEARED. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150623. CONCLUSION: THE NATURE OF THE CRACKING AND SMEARED PRINTING SUGGEST THAT THE DAMAGE WAS CAUSED BY THE CHAMBER COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL/ALCOHOL, WHICH HAS RESULTED IN ENVIRONMENTAL STRESS 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 ONE MR290V HUMIDIFICATION CHAMBER WAS FOUND TO BE LEAKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA AN FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT ONE MR290V HUMIDIFICATION CHAMBER WAS FOUND TO BE LEAKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839088 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 150623

    Patients

    Seq Age Sex Outcome Treatment
    1