BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3273186 · Received August 8, 2013

    Report

    Report Number
    9611451-2013-00581
    Event Type
    Malfunction
    Date Received
    August 8, 2013
    Report Date
    July 12, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FPH IN (B)(4) AND WAS VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED THAT THE CHAMBER DOME WAS CRACKED ALONG THE BASE, BETWEEN THE BAFFLE AND ONE OF THE PORTS. A SECOND CRACK WAS ALSO OBSERVED ABOVE THE BRACKET. THERE WERE ALSO STRESS MARKS FOUND BETWEEN THE BAFFLE AND THE OTHER PORT, WHICH WERE PARALLEL TO THE BASE. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 130416. CONCLUSION: WE WERE UNABLE TO CONFIRM DEFINITIVELY THE ROOT CAUSE OF THE REPORTED FAULT; HOWEVER, BASED ON THE NATURE OF THE DAMAGE OBSERVED, IT IS LIKELY THAT THE STRESS MARKS ON THE CHAMBER DOME CAUSED THE REPORTED CRACKING. EVERY MR290 CHAMBER IS PRESSURE TESTED TO 8KPA FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS THESE TESTS IS REJECTED. THIS SUGGESTS THAT THE SUBJECT CHAMBER WAS DAMAGED AFTER IT WAS RELEASED FOR DISTRIBUTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 AUTOFEED HUMIDIFICATION 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 TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS CRACKED, CAUSING THE WATER TO LEAK. THIS WAS OBSERVED BEFORE PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374077 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 130416

    Patients

    Seq Age Sex Outcome Treatment
    1 RT330 INFANT OPTIFLOW TUBING KIT