BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3854940 · Received June 9, 2014

    Report

    Report Number
    9611451-2014-00493
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Report Date
    May 8, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKE HEALTHCARE IN (B)(4) WHERE THEY WERE VISUALLY INSPECTED. ONE OF THE RETURNED DEVICES WAS FROM LOT 130518 (DATE OF MANUFACTURE: 18 MAY 2013) AND THE OTHER WAS FROM LOT 130715 (DATE OF MANUFACTURE: 15 JULY 2013). RESULTS: VISUAL INSPECTION OF THE CHAMBER FROM LOT 130715 REVEALED A CRACK UNDERNEATH THE BAFFLE. THE CRACK SHOWED STRESS MARKS AND SCRATCHES WERE NOTED ON THE SIDE OF THE CHAMBER DOME. ADDITIONAL STRESS MARKS WERE NOTED BETWEEN CHAMBER PORT AND HINGE BRACKET. VISUAL INSPECTION OF THE OTHER CHAMBER REVEALED DENTS ON THE BASE. A VERTICAL CRACK WAS ALSO OBSERVED UNDER THE CHAMBER PORTS. A LOT CHECK REVEALED NO OTHER COMPLAINTS FOR LOT 130518 AND LOT 130715. CONCLUSION: BASED ON THE ABOVE INSPECTION THE DAMAGE OBSERVED ON THE RETURNED CHAMBERS WAS MOST LIKELY CAUSED BY SOME FORM OF IMPACT, POSSIBLY DURING TRANSPORTATION OR STORAGE OF THE CHAMBERS. 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. THIS SUGGESTS THE RETURNED CHAMBERS WERE DAMAGED AFTER THEY WERE RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE: "DO NOT USE THE CHAMBER IF THE SEALS ARE NOT INTACT WHEN RECEIVED, OR IF IT HAS BEEN DROPPED." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "SET APPROPRIATE VENTILATOR ALARMS."

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING WHEN CONNECTED TO A VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING WHEN CONNECTED TO A VENTILATOR. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336537 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290HFV 130715

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH RT235 INFANT BREATHING CIRCUIT| FPH RT235 INFANT BREATHING CIRCUIT