BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1220366 · Received October 31, 2008

    Report

    Report Number
    9611451-2008-00639
    Event Type
    Malfunction
    Date Received
    October 31, 2008
    Report Date
    October 3, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE DEVICE IS EN ROUTE TO THE MANUFACTURER FOR INSPECTION. WE WERE UNABLE TO CARRY OUT A LOT CHECK AS NO LOT INFORMATION WAS PROVIDED WITH THIS COMPLAINT. WE WILL PROVIDE A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY (B) (6) REPORTED THAT AN RT200 ADULT BREATHING CIRCUIT WAS NOT HEATING. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT200

    Patients

    Seq Age Sex Outcome Treatment
    1