BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9611451-2007-00496

    MDR report key: 960968 · Received December 11, 2007

    Report

    Report Number
    9611451-2007-00496
    Event Type
    Malfunction
    Date Received
    December 11, 2007
    Date of Event
    November 12, 2007
    Report Date
    November 12, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO COMPLAINT DEVICE OR PHOTO'S PROVIDED. LOT NUMBER PROVIDED (070730). OUR INVESTIGATION WAS BASED ON THE EVENT DESCRIPTION AND RESULTS FROM PREVIOUS INVESTIGATIONS. OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. THE MISSING COMPONENTS ARE DUE TO OPERATOR ERROR IN THE PACKING PROCESS. CONCLUSION: THE DEVICE WAS OUT OF SPECIFICATION. THIS WILL BE BROUGHT TO THE ATTENTION OF MFG TEAM MEMBERS. WE ARE AWARE OF OTHER SIMILAR COMPLAINTS. THE OCCURRENCE RATE IS APPROX 0.03% WORLDWIDE FOR THE LAST YR. WE WILL CONTINUE TO MONITOR ALL COMPLAINTS FOR SIMILAR FAULTS. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT.

    Description of Event or Problem · 1

    A HOSP REPORTED THAT 4 UNITS FROM A CARTON WERE MISSING THE COMPONENT THAT "CONNECTS TO THE NASA PRONGS". WE BELIEVE THAT THE MISSING COMPONENT IS THE OFFSET ADAPTER. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BTT FISHER & PAYKEL HEALTHCARE, LTD. RT329 070730

    Patients

    Seq Age Sex Outcome Treatment
    1 YR