BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRVO2 HUMIDIFIER

    MDR report key: 2970811 · Received February 20, 2013

    Report

    Report Number
    9611451-2013-00134
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 22, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO FAULT WAS FOUND WITH THE COMPLAINT AIRVO2 DEVICE AND WE WERE NOT ABLE TO CONFIRM THE REPORTED FAULT. WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. THE COMPLAINT AIRVO2 DEVICE WAS SET UP WITH AN MR290 CHAMBER, A HEATED BREATHING TUBE, AND A TRACHEOSTOMY INTERFACE. THE COMPLAINT AIRVO2 DEVICE WAS PERFORMANCE TESTED IN ACCORDANCE WITH THE PRODUCT TECHNICAL MANUAL AND PASSED ALL OF THE RELEVANT PERFORMANCE TESTS. DURING OUR EVALUATION, THE COMPLAINT AIRVO2 DEVICE WAS ABLE TO REACH 37 DEGREES CELSIUS AT 50 LITERS PER MINUTE (LPM) WHEN SET TO THESE PARAMETERS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT AIRVO2 DEVICE IS CURRENTLY IN TRANSIT TO FISHER & PAYKEL HEALTHCARE (B)(4). WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE COMPLAINT DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE COMPLAINT AIRVO2 DEVICE DID NOT REACH THE SET TEMPERATURE OF 37 DEGREES CELSIUS AT A FLOW SETTING OF 50 LITERS PER MINUTE (LPM), AS THE DEVICE REPORTEDLY DISPLAYED 35 DEGREES CELSIUS. THE HOSPITAL REPORTED THAT THE SETTINGS WERE THEN CHANGED TO 37 DEGREES CELSIUS WITH A FLOW SETTING OF 30 LPM, WHICH WERE ACHIEVED BY THE COMPLAINT AIRVO2 DEVICE. THE HOSPITAL ALLEGED THAT A TRACHEOTOMY CANNULA WAS OCCLUDED BY PATIENT SECRETION, WHILE IN USE WITH THE COMPLAINT AIRVO2 DEVICE TO DELIVER HUMIDIFICATION THERAPY. THE PATIENT WAS ALLEGED TO HAVE DIFFICULTY BREATHING DUE TO OCCLUSION OF FLOW CAUSED BY PATIENT SECRETION. NO FURTHER PATIENT CONSEQUENCE WAS REPORTED. THE TRACHEOTOMY CANNULA WAS REPLACED WITH A NEW ONE AND THE PATIENT WAS ABLE TO CONTINUE THERAPY.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE COMPLAINT AIRVO2 DEVICE DID NOT REACH THE SET TEMPERATURE OF 37 DEGREES CELSIUS AT A FLOW SETTING OF 50 LITERS PER MINUTE (LPM), AS THE DEVICE REPORTEDLY DISPLAYED 35 DEGREES CELSIUS. THE HOSPITAL REPORTED THAT THE SETTINGS WERE THEN CHANGED TO 37 DEGREES CELSIUS WITH A FLOW SETTING OF 30 LPM, WHICH WERE ACHIEVED BY THE COMPLAINT AIRVO2 DEVICE. THE HOSPITAL ALLEGED THAT A TRACHEOTOMY CANNULA WAS OCCLUDED BY PATIENT SECRETION, WHILE IN USE WITH THE COMPLAINT AIRVO2 DEVICE TO DELIVER HUMIDIFICATION THERAPY. THE PATIENT WAS ALLEGED TO HAVE DIFFICULTY BREATHING DUE TO OCCLUSION OF FLOW CAUSED BY PATIENT SECRETION. NO FURTHER PATIENT CONSEQUENCE WAS REPORTED. THE TRACHEOTOMY CANNULA WAS REPLACED WITH A NEW ONE AND THE PATIENT WAS ABLE TO CONTINUE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74864 AIRVO2 HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD PT101

    Patients

    Seq Age Sex Outcome Treatment
    1