BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVO2 HUMIDIFIER

    MDR report key: 5734824 · Received June 19, 2016

    Report

    Report Number
    9611451-2016-00270
    Event Type
    Malfunction
    Date Received
    June 19, 2016
    Date of Event
    May 26, 2016
    Report Date
    May 26, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT AIRVO HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED 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 NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 150428. 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. AS PART OF OUR ONGOING PRODUCT IMPROVEMENT INITIATIVES, WE RECENTLY IMPLEMENTED A SOAK TEST FOR 100% TESTING OF THE SPEAKER HARNESS ON THE AIRVO PRODUCTION LINE, WHICH IDENTIFIES AND DISCARDS ANY FAULTY SPEAKERS PRIOR TO ASSEMBLY INTO THE AIRVO. THE SUBJECT AIRVO WAS MANUFACTURED PRIOR TO IMPLEMENTATION OF THE SOAK TEST. 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 WARNS THE USER: PRIOR TO EACH PATIENT USE, ENSURE THAT THE AUDITORY ALARM SIGNAL IS AUDIBLE BY CONDUCTING THE ALARM SYSTEM FUNCTIONALITY CHECK DESCRIBED IN THE ALARMS SECTION THE ALARM SYSTEM FUNCTIONALITY CHECK INSTRUCTS THE USER HOW TO CHECK THE ALARM FUNCTION 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. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389159 AIRVO2 HUMIDIFIER AIRVO2 HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101 150428

    Patients

    Seq Age Sex Outcome Treatment
    1