BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MYAIRVO HUMIDIFIER

    MDR report key: 5209756 · Received November 8, 2015

    Report

    Report Number
    9611451-2015-00468
    Event Type
    Malfunction
    Date Received
    November 8, 2015
    Report Date
    October 13, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MYAIRVO 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 NORMALLY. THE VISUAL ALERTS WERE OPERATING, 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 140129. 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 ADJUSTED THE PROCESS AND TAKEN STEPS TO ENSURE THAT EACH SPEAKER IS CHECKED FOLLOWING THE GLUING PROCESS AND THAT ANY FOUND FAULTY ARE DISCARDED. THE SUBJECT AIRVO WAS MANUFACTURED BEFORE IMPLEMENTATION OF THESE MEASURES. THE MYAIRVO 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 HEALTHCARE FACILITY IN (B)(6) REPORTED THAT A PT100 MYAIRVO HUMIDIFIER HAD NO AUDIBLE ALARMS. THIS WAS FOUND AFTER PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739874 MYAIRVO HUMIDIFIER MYAIRVO HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT100 140129

    Patients

    Seq Age Sex Outcome Treatment
    1