BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVO2 HUMIDIFIER

    MDR report key: 5199303 · Received November 3, 2015

    Report

    Report Number
    9611451-2015-00460
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Report Date
    October 5, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K131895
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE COMPLAINT AIRVO HUMIDIFIER HAS NOT BEEN RECEIVED FOR EVALUATION. THE HOSPITAL HAS REPORTED THAT THE AUDIBLE ALARM WAS NO LONGER WORKING. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT NUMBER 141215. PREVIOUS INVESTIGATIONS INTO FAULTY SPEAKERS HAVE SHOWN THAT THE PROBLEM IS USUALLY THE RESULT OF AN OPEN CIRCUIT IN THE SPEAKER. 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. THE SUBJECT AIRVO WAS MANUFACTURED BEFORE THE SUPPLIER IMPLEMENTED THESE ADDITIONAL CHECKS. 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." DEVICE EVALUATED AT FPH REGIONAL OFFICE.

    Additional Manufacturer Narrative · 1

    (B)(\4). METHOD: THE COMPLAINT AIRVO HUMIDIFIER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. 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. 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 NUMBER 141215. 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. ADDITIONAL CHECKS HAVE ALSO BEEN IMPLEMENTED DURING PRODUCTION AT OUR FACILITY TO ENSURE THE SPEAKER IS WORKING AT THE TIME OF MANUFACTURE OF THE AIRVO. THE SUBJECT AIRVO WAS MANUFACTURED BEFORE IMPLEMENTATION OF THESE MEASURES.. 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF AN AIRVO 2 HUMIDIFIER WAS NO LONGER WORKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT THE AUDIBLE ALARM OF AN AIRVO 2 HUMIDIFIER WAS NO LONGER WORKING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    728728 AIRVO2 HUMIDIFIER AIRVO2 HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE LTD PT101 141215009332

    Patients

    Seq Age Sex Outcome Treatment
    1