BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVO2 HUMIDIFIER

    MDR report key: 5445505 · Received February 18, 2016

    Report

    Report Number
    9611451-2016-00057
    Event Type
    Malfunction
    Date Received
    February 18, 2016
    Date of Event
    January 28, 2016
    Report Date
    January 28, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130304. CONCLUSION: 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 SUBJECT AIRVO WAS MANUFACTURED PRIOR TO THESE IMPROVEMENTS. THE AIRVO 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 THAT THE AUDIBLE ALARM OF AN AIRVO 2 HUMIDIFIER WAS NOT FUNCTIONING. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100144 AIRVO2 HUMIDIFIER AIRVO2 HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101 130304

    Patients

    Seq Age Sex Outcome Treatment
    1