BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED CHAMBER

    MDR report key: 2278218 · Received October 5, 2011

    Report

    Report Number
    9611451-2011-00617
    Event Type
    Malfunction
    Date Received
    October 5, 2011
    Date of Event
    August 23, 2011
    Report Date
    September 8, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED COMPLAINT MR290 CHAMBER WAS VISUALLY INSPECTED AND CONNECTED TO A WATER BAG FOR TESTING. RESULTS: WATER LEAK WAS FOUND AT THE FEEDSET VENT. THE CHAMBER WAS REMOVED FROM THE WATER BAG AND THE VENT WAS REMOVED FROM THE SPIKE FOR VISUAL INSPECTION. NO DAMAGE WAS FOUND. CONCLUSION: WE WERE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAULT. 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 LEAK DEVELOPED POST PRODUCTION, POSSIBLY DURING STORAGE OR TRANSPORT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS TYPE FOR LOT 110117. THE USER INSTRUCTIONS WHICH ACCOMPANY THE MR290 CHAMBER STATE "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)(4) REPORTED VIA A DISTRIBUTOR THAT WATER LEAKED FROM THE BAG SPIKE WHEN THE WATER FEEDSET TUBE OF AN MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS CONNECTED TO A WATER BOTTLE. THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 110117

    Patients

    Seq Age Sex Outcome Treatment
    1