BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1706475 · Received May 27, 2010

    Report

    Report Number
    9611451-2010-00305
    Event Type
    Other
    Date Received
    May 27, 2010
    Report Date
    May 7, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DISTRIBUTOR REPORTED THAT THE PRODUCT MANUAL WAS NOT PROVIDED WITH THE MR850 RESPIRATORY HUMIDIFIER. AN INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT DESCRIPTION BECAUSE THE DEVICE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE. IT IS LIKELY THAT THE MANUAL WAS OMITTED FROM THE MR850 PACKAGING DUE TO AN OPERATOR ERROR DURING THE PACKAGING PROCESS. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 100323. OUR MONITORING AND TRENDING SHOWS THAT WE HAVE RECEIVED THREE (3) OTHER COMPLAINTS OF THIS NATURE FOR THE M4850 HUMIDIFIER SYSTEM IN THE PAST 12 MONTHS.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) REPORTED THAT THEY RECEIVED AN MR850 RESPIRATORY HUMIDIFIER WITHOUT A PRODUCT TECHNICAL MANUAL. THE DISTRIBUTOR NOTICED THAT THE MANUAL WAS MISSING FROM THE PACKAGING PRIOR TO PT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE, LTD. MR850GJU 100323

    Patients

    Seq Age Sex Outcome Treatment
    1