BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVO2 HUMIDIFIER

    MDR report key: 4869939 · Received June 25, 2015

    Report

    Report Number
    9611451-2015-00293
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    May 11, 2015
    Report Date
    June 2, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: DUE TO THE RECENTLY CONFIRMED MIDDLE EAST RESPIRATORY SYNDROME (MERS) CASES IN (B)(6) AND THE POTENTIAL RISK OF INFECTION, THE COMPLAINT AIRVO HUMIDIFIER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(6) FOR INVESTIGATION. IT WAS DESTROYED IN (B)(6). OUR ANALYSIS IS ACCORDINGLY BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL STAFF AND EVALUATION AT OUR KOREAN REGIONAL OFFICE. DURING TESTING AT OUR KOREAN OFFICE THE AIRVO FUNCTIONED NORMALLY. THE VISUAL ALERTS WERE OPERATING, HOWEVER NO AUDIBLE ALARM WAS HEARD. IT WAS THUS CONFIRMED THAT THE AUDIBLE ALARM WAS NOT FUNCTIONING ON THE SUBJECT AIRVO. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140422. THE SUPPLIER OF THE SPEAKER UNIT WAS NOTIFIED AND THEY HAVE CARRIED OUT AN INVESTIGATION. THE PROBLEM HAS BEEN TRACED TO AN ISSUE WITH THE GLUING PROCESS. THE SUPPLIER HAS TAKEN STEPS TO ENSURE THAT EACH SPEAKER IS CHECKED FOLLOWING THE GLUING PROCESS AND ANY FOUND FAULTY ARE DISCARDED. ADDITIONAL CHECKS HAVE ALSO BEEN IMPLEMENTED DURING PRODUCTION AT OUR FACILITY TO ENSURE THE SPEAKER IS WORKING AT THE TIME OF MANUFACTURE OF THE AIRVO. THE AIRVO 2 USER MANUAL STATES THAT THE "AIRVO IS FOR THE TREATMENT OF SPONTANEOUSLY BREATHING PATIENTS WHO WOULD BENEFIT FROM RECEIVING HIGH-FLOW, WARMED AND HUMIDIFIED RESPIRATORY GASES." AND THAT "THE UNIT IS NOT INTENDED FOR LIFE SUPPORT." THE USER MANUAL ALSO CONTAINS INSTRUCTIONS ON HOW TO CHECK THE ALARM SYSTEM FUNCTIONALITY AND STATES THAT "IF EITHER ALARM SIGNAL IS ABSENT, DO NOT USE THE UNIT. CONTACT YOUR FISHER & PAYKEL HEALTHCARE REPRESENTATIVE."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT AN AIRVO 2 HUMIDIFIER DID NOT HAVE AN AUDIBLE ALARM. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411299 AIRVO2 HUMIDIFIER AIRVO2 HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101 140422002603

    Patients

    Seq Age Sex Outcome Treatment
    1