BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVO2 HUMIDIFIER

    MDR report key: 5536937 · Received March 30, 2016

    Report

    Report Number
    9611451-2016-00119
    Event Type
    Malfunction
    Date Received
    March 30, 2016
    Report Date
    March 3, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT AIRVO HUMIDIFIER WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE IN (B)(4). THE DEVICE WAS PERFORMANCE TESTED AND THE AUDIBLE ALARM FUNCTION WAS CHECKED. AND ELECTRICALLY TESTED. RESULTS: DURING TESTING THE AIRVO TURNED ON AND FUNCTIONED, HOWEVER NO AUDIBLE ALARM WAS HEARD. THE FAULT WAS TRACED TO A FAULTY SPEAKER AND ELECTRICAL RESISTANCE TESTING SHOWED THAT THE SPEAKER'S RESISTANCE WAS OPEN CIRCUIT. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 150407. 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 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 WORKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190006 AIRVO2 HUMIDIFIER AIRVO2 HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101 150407

    Patients

    Seq Age Sex Outcome Treatment
    1