BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1854590 · Received September 9, 2010

    Report

    Report Number
    9611451-2010-00541
    Event Type
    Malfunction
    Date Received
    September 9, 2010
    Date of Event
    August 12, 2010
    Report Date
    August 12, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: ONE COMPLAINT DEVICE HAS LOT NUMBER 100420. THE SECOND COMPLAINT DEVICE HAS LOT NUMBER 100507. THE TWO COMPLAINT DEVICES HAVE NOT BEEN RETURNED TO THE MFR AS THEY HAVE BEEN DISCARDED. IT HAS BEEN VISUALLY INSPECTED BY A FISHER & PAYKEL HEALTHCARE SERVICE ENGINEER AT OUR REGIONAL OFFICE IN (B)(4). RESULTS: THE VISUAL INSPECTION CONFIRMED A CRACK ON THE SIDE OF THE CHAMBER DOME. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR BOTH OF THESE LOT NUMBERS. CONCLUSION: ALL MR290 CHAMBERS ARE PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. ANY CHAMBER WHICH FAILS EITHER OF THESE TESTS IS REJECTED. THIS SUGGESTS THAT THE CHAMBER WAS DAMAGED POST PRODUCTION, POSSIBLY DURING TRANSPORT OR STORAGE AT THE CUSTOMER FACILITY. THE DEVICE USER INSTRUCTIONS STATE THE FOLLOWING: "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". (B)(4).

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT TWO MR290 AUTOFEED HUMIDIFICATION CHAMBERS WERE "BROKEN". THIS WAS FOUND PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR290V 100420

    Patients

    Seq Age Sex Outcome Treatment
    1