BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVO2 HUMIDIFIER

    MDR report key: 3885134 · Received June 19, 2014

    Report

    Report Number
    9611451-2014-00543
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Report Date
    May 23, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AIRVO IS A HUMIDIFIER WITH INTEGRATED FLOW GENERATOR THAT DELIVERS WARMED AND HUMIDIFIED RESPIRATORY GASES TO SPONTANEOUSLY BREATHING PATIENTS THROUGH A VARIETY OF PATIENT INTERFACES. METHOD: THE COMPLAINT AIRVO HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. RESULTS: THE COMPLAINT DEVICE WAS TESTED BY CAUSING AN ALARM TO OCCUR. A WARNING MESSAGE WAS DISPLAYED BUT THERE WAS NO AUDIBLE ALARM. THE FAULT WAS TRACED TO A FAULTY SPEAKER AND ELECTRICAL RESISTANCE TESTING SHOWED THAT SPEAKER WAS OPEN CIRCUIT. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR LOT NUMBER 140217. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE SPEAKER RESISTANCE TO BECOME OPEN CIRCUIT. 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." WE HAVE ONLY RECEIVED ONE OTHER COMPLAINT OF THIS TYPE FOR THE AIRVO.

    Description of Event or Problem · 1

    A HOSPITAL IN THE (B)(6) REPORTED THAT THE ALARM ON A PT101 AIRVO HUMIDIFIER HAD A 'DISTORTED AUDIBLE SOUND'. THIS WAS REPORTED BY A HOSPITAL TECHNICIAN AND NOT DURING PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360701 AIRVO2 HUMIDIFIER AIRVO2 HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101 140217

    Patients

    Seq Age Sex Outcome Treatment
    1