BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 5707917 · Received June 8, 2016

    Report

    Report Number
    9611451-2016-00253
    Event Type
    Malfunction
    Date Received
    June 8, 2016
    Date of Event
    May 10, 2016
    Report Date
    May 10, 2016
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A CRACK IN THE CHAMBER DOME BENEATH ONE OF THE PORTS. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT NUMBER 151107. CONCLUSION: THE POSITION AND NATURE OF THE CRACKING UNDER ONE OF THE PORTS INDICATES THAT THE CRACK WAS MOST LIKELY CAUSED BY EXCESSIVE PRESSURE DURING USE. THIS WAS FURTHER CONFIRMED BY INFORMATION ABOUT THE VENTILATOR SETTINGS USED DURING THE INCIDENT. EVERY MR290 CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THAT THE MAXIMUM OPERATING PRESSURE IS 8 KPA. AND ALSO CONTAIN THE FOLLOWING WARNING: USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE MAY LEAD TO CRACKING, WATER LEAKAGE AND, ON RARE OCCASIONS, COULD LEAD TO A LOSS OF VENTILATION PRESSURE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR290V HUMIDIFICATION CHAMBER DOME HAD CRACKED AFTER 20 HOURS OF PATIENT USE. THEY FURTHER REPORTED THAT THIS AFFECTED THE PATIENT THERAPY DUE TO A 50% LEAKAGE OF THE INSPIRATORY VOLUME. NO FURTHER PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360534 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1511070306

    Patients

    Seq Age Sex Outcome Treatment
    1