BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 3318283 · Received August 30, 2013

    Report

    Report Number
    9611451-2013-00654
    Event Type
    Malfunction
    Date Received
    August 30, 2013
    Date of Event
    August 1, 2013
    Report Date
    August 2, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290 CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. IT WAS VISUALLY INSPECTED AND CONNECTED TO A WATER BAG. RESULTS: UPON CONNECTING THE RETURNED CHAMBER TO A WATER BAG, A SMALL DROP OF WATER BEGAN TO BUILD AT THE CONNECTION BETWEEN THE FEEDSET TUBE AND WATER BAG SPIKE. A SUFFICIENT AMOUNT OF GLUE WAS PRESENT AROUND THE SPIKE TUBING CONNECTION; HOWEVER THE GLUE HAD NOT BONDED PROPERLY. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120509. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE LEAK OBSERVED ON THE RETURNED MR290 CHAMBER. ALL CHAMBERS ARE PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE AND ANY HOLES OR LEAKS IN THE FEEDSET ARE IDENTIFIED DURING THIS PROCESS. THIS SUGGESTS THAT THE MR290 CHAMBER WAS WITHIN SPECIFICATION PRIOR TO BEING RELEASED FOR DISTRIBUTION. (B)(4). THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARM." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE FEEDSET LINE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND TO BE "SNAPPED" WHILE THE VENTILATOR WAS BEING SET UP. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428320 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 1205090105

    Patients

    Seq Age Sex Outcome Treatment
    1