BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1031420 · Received April 18, 2008

    Report

    Report Number
    9611451-2008-00204
    Event Type
    Malfunction
    Date Received
    April 18, 2008
    Date of Event
    March 3, 2008
    Report Date
    March 3, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A MALFUNCTION THAT HAS BEEN REPORTED TO FISHER & PAYKEL HEALTHCARE BY A HOSPITAL. THE PRODUCT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE RETURNED DEVICE WAS VISUALLY INSPECTED. RESULTS: THE CONNECTOR ON THE DRY LINE OF THE BREATHING CIRCUIT WAS MISSING. CONCLUSION: IT IS LIKELY THAT THE PART WAS OMITTED DURING PACKING. THERE IS CURRENTLY AN OPEN CAPA ADDRESSING THE ISSUE OF MISSING PARTS. OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.0029%.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO OUR DISTRIBUTOR THAT ONE OF THE WHITE CONNECTORS WAS MISSING FROM THE RT206 ADULT BREATHING CIRCUIT PACKAGE. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE, LTD. RT206 071129

    Patients

    Seq Age Sex Outcome Treatment
    1