BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1170677 · Received September 16, 2008

    Report

    Report Number
    9611451-2008-00536
    Event Type
    Malfunction
    Date Received
    September 16, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 18, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PS34509. THE PRODUCT REFERRED TO IN THE EVENT DESCRIPTION IS NOT SOLD IN THE USA, BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. THE RETURNED BREATHING CIRCUIT WAS VISUALLY INSPECTED FOR MISSING COMPONENTS. RESULTS: THERE WAS NO ELBOW CONNECTOR IN THE RETURNED BREATHING CIRCUIT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS. CONCLUSION: THE COMPONENT WAS MOST LIKELY OMITTED DURING OUR PACKING PROCESS. (B) (4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B) (4) REPORTED VIA OUR DISTRIBUTOR THAT THE ELBOW CONNECTOR WAS MISSING FROM THE PACKAGE OF AN RT206 ADULT BREATHING CIRCUIT. 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. RT206 080619

    Patients

    Seq Age Sex Outcome Treatment
    1