BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVO2 HUMIDIFIER

    MDR report key: 5768037 · Received July 4, 2016

    Report

    Report Number
    9611451-2016-00298
    Event Type
    Malfunction
    Date Received
    July 4, 2016
    Report Date
    June 6, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT AIRVO HUMIDIFIER WAS RECEIVED AT OUR FISHER & PAYKEL HEALTHCARE (FPH) REGIONAL OFFICE IN (B)(4) WHERE IT WAS INSPECTED BY A TRAINED FPH TECHNICIAN. THE DEVICE WAS PERFORMANCE TESTED AND THE AUDIBLE ALARM FUNCTION WAS CHECKED. RESULTS: DURING TESTING IT WAS FOUND THAT THE VISUAL ALERTS ON THE COMPLAINT AIRVO WERE OPERATING, HOWEVER NO AUDIBLE ALARM WAS HEARD. PREVIOUS INVESTIGATIONS INTO THIS TYPE OF FAILURE HAVE IDENTIFIED THAT THE PROBEM IS CAUSED BY A FAULTY SPEAKER AND ELECTRICAL RESISTANCE TESTING HAS SHOWN THE SPEAKER'S RESISTANCE TO BE OPEN CIRCUIT. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 150817. 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 ONGING 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 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 DISTRIBUTOR IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF AN AIRVO 2 HUMIDIFIER WAS NOT WORKING. THIS WAS FOUND BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421943 AIRVO2 HUMIDIFIER AIRVO2 HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101 150817

    Patients

    Seq Age Sex Outcome Treatment
    1