BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 1891487 · Received November 4, 2010

    Report

    Report Number
    9611451-2010-00675
    Event Type
    Malfunction
    Date Received
    November 4, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 22, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RETURNED MR290 CHAMBER WAS VISUALLY INSPECTED FOR DAMAGE. RESULTS: A SMALL DENT WAS OBSERVED IN THE MIDDLE OF THE CHAMBER BASE, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100324. CONCLUSION: ALL MR290 CHAMBERS ARE VISUALLY INSPECTED FOR DAMAGE AND ARE PRESSURE TESTED FOR LEAKS PRIOR TO PACKING. ANY CHAMBER WHICH FAILS EITHER TEST IS DISCARDED. THIS SUGGESTS THAT THE CHAMBER HAD BEEN DAMAGED POST-PRODUCTION, POSSIBLY DURING TRANSPORT OR STORAGE. THE MR290 USER INSTRUCTIONS WARN THE USER NOT TO USE THE MR290 IF IT HAS BEEN DROPPED. OUR TRENDING AND MONITORING OF COSMETIC DEFECTS ON MR290 CHAMBERS HAS A RATE OF OCCURRENCE OF (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON RECEIPT OF THE DEVICE AND COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE BASE OF A NEW MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND TO BE DENTED WHEN IT WAS REMOVED FROM THE PACKAGING.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A DISTRIBUTOR THAT THE BASE OF A NEW MR290 AUTOFEED HUMIDIFICATION CHAMBER WAS FOUND TO BE DENTED WHEN IT WAS REMOVED FROM THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 100324

    Patients

    Seq Age Sex Outcome Treatment
    1