BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2001216 · Received February 24, 2011

    Report

    Report Number
    9611451-2011-00093
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 28, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO HAVE THE COMPLAINT DEVICE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION. CORRECTION OF DEVICE MANUFACTURER DATE - 11/12/2010.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY ENDEAVOURING TO HAVE THE COMPLAINT DEVICE RETURNED TO FISHER & PAYKEL HEALTHCARE (B)(4). WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT CHAMBER WAS VISUALLY INSPECTED. RESULTS: THE VISUAL INSPECTION REVEALED A ROUGH BREAK IN THE FEEDSET TUBE WHERE IT IS INSERTED INTO THE CHAMBER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS LOT NUMBER. CONCLUSION: THE ROOT CAUSE OF THIS REPORTED FAULT COULD NOT BE IDENTIFIED. HOWEVER THE DAMAGE APPEARS TO BE DUE TO THE TUBE BEING PULLED, AWAY FROM THE DOME, POSSIBLY DUE TO THE FEEDSET BEING CAUGHT OR PLACED UNDER TENSION. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET WOULD BE IDENTIFIED DURING THIS PROCESS. OUR USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 STATE THE FOLLOWING: "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED THERE WAS WATER LEAKAGE BETWEEN THE CONNECTION OF THE WATER FEEDSET TUBE AND THE CHAMBER INLET OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER DURING SET UP. THE MR290V IS PART OF A RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT KIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THERE WAS WATER LEAKAGE BETWEEN THE CONNECTION OF THE WATER FEEDSET TUBE AND THE CHAMBER INLET OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER DURING SET UP. THE MR290V IS PART OF A RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT KIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(4) REPORTED THERE WAS WATER LEAKAGE BETWEEN THE CONNECTION OF THE WATER FEEDSET TUBE AND THE CHAMBER INLET OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER DURING SET UP. THE MR290V IS PART OF A RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT KIT. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 101112

    Patients

    Seq Age Sex Outcome Treatment
    1 RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT| RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT| RT224 INFANT CONTINUOUS FLOW BREATHING CIRCUIT