BEUDAMED
    FDA Adverse Event Other Summary report: N

    MR880 TRACHE DIRECT CONNECTION

    MDR report key: 1684845 · Received May 7, 2010

    Report

    Report Number
    9611451-2010-00271
    Event Type
    Other
    Date Received
    May 7, 2010
    Report Date
    April 8, 2010
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). OUR INVESTIGATION IS CURRENTLY IN PROGRESS. WE WILL PROVIDE A F/U REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THE FOLLOWING TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE: "I WISH TO ADVISE YOU OF AN INCIDENT THAT OCCURRED HERE AT (B)(6) HOSPITAL WITH YOUR PRODUCT "TRACHEOSTOMY DIRECT CONNECTION". A JUNIOR INTENSIVE CARE NURSE INSERTED AN INNER CANNULA IN 2 PATIENTS WITH THIS PRODUCT BEING USED, BUT INSTEAD OF DISCONNECTING FROM THE TRACHE TUBE ITSELF IT WAS INSERTED THROUGH THE OPENING OF THE PRODUCT. IT OCCURRED ON 2 PATIENTS". IT WAS REPORTED TO THE FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT ONE PT DESATURATED TO 89% AND THE OTHER PT MAINTAINED AN OXYGEN SATURATION LEVEL AROUND 100%. IT WAS REPORTED THAT NEITHER PATIENT WAS COMPROMISED AND NO FURTHER TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MR880 TRACHE DIRECT CONNECTION BZA FISHER & PAYKEL HEALTHCARE, LTD. OPT570

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention