BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVO2 HUMIDIFIER

    MDR report key: 5668906 · Received May 19, 2016

    Report

    Report Number
    9611451-2016-00217
    Event Type
    Malfunction
    Date Received
    May 19, 2016
    Date of Event
    April 18, 2016
    Report Date
    April 21, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT AIRVOS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE TWO COMPLAINT AIRVO HUMIDIFIERS WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE IN (B)(4). THE SECOND DEVICE HAD SERIAL NUMBER (B)(4), MANUFACTURED ON MARCH 4, 2015. THE DEVICES WERE PERFORMANCE TESTED AND THE AUDIBLE ALARM FUNCTION WAS CHECKED AND ELECTRICALLY TESTED. RESULTS: DURING TESTING BOTH AIRVOS 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 150202 AND NO OTHER COMPLAINTS OF THIS NATURE FOR LOT 150304. CONCLUSION: THE SUPPLIER OF THE SPEAKER UNIT WAS NOTIFIED AND THEY HAVE CARRIED OUT AN INVESTIGATION. THE PROBLEM WAS 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 AIRVOS WERE 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 ALSO CONTAINS INSTRUCTIONS ON HOW TO CHECK THE ALARM SYSTEM FUNCTIONALITY

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF TWO AIRVO 2 HUMIDIFIERS WAS NOT WORKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF TWO AIRVO 2 HUMIDIFIERS WAS NOT WORKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321409 AIRVO2 HUMIDIFIER AIRVO2 HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101 150202

    Patients

    Seq Age Sex Outcome Treatment
    1