BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 4283029 · Received November 27, 2014

    Report

    Report Number
    9611451-2014-00868
    Event Type
    Malfunction
    Date Received
    November 27, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 29, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED VERTICAL CRACKS ON THE CHAMBER DOME. CRAZING PATTERN WAS NOTED NEAR THE CRACKS. THE CHAMBER DOME WAS ALSO SLIGHTLY BULGED NEAR THE CHAMBER BASE. BROWN SUBSTANCE WAS ALSO FOUND ON THE CHAMBER DOME AND ALSO ON THE PRIMARY FLOAT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 140615. CONCLUSION: BASED ON THE INSPECTION CARRIED OUT IT IS LIKELY THAT THE DAMAGE WAS CAUSED BY THE CHAMBER COMING INTO CONTACT WITH A SOLUTION CONTAINING ETHANOL/ALCOHOL RESULTING IN ENVIRONMENTAL STRESS CRACKING OF THE CHAMBER DOME. THE BROWN SUBSTANCE NOTED ON THE PRIMARY FLOAT AND ON THE CHAMBER DOME IS LIKELY TO BE DEPOSITS FROM USING NON-STERILE WATER. EVERY MR290 CHAMBER IS PRESSURE TESTED 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. THIS SUGGESTS THE CHAMBER WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE CUSTOMER ONLY REPORTED THE CRACKING AFTER SEVEN DAYS OF USE. 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; USE USP STERILE WATER FOR INHALATION OR EQUIVALENT. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE THAT WATER LEAKED FROM AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER AFTER SEVEN DAYS OF USE. THEY FURTHER REPORTED A CRACK ON THE CHAMBER DOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770246 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1406150304

    Patients

    Seq Age Sex Outcome Treatment
    1