BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT CONTINUOUS FLOW BREATHING CIRCUIT

    MDR report key: 2120912 · Received June 12, 2011

    Report

    Report Number
    9611451-2011-00349
    Event Type
    Malfunction
    Date Received
    June 12, 2011
    Date of Event
    May 13, 2011
    Report Date
    May 16, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT KIT IS EN ROUTE TO FISHER & PAYKEL HEALTHCARE FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE RECEIVE THE COMPLAINT DEVICE AND HAVE COMPLETED OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT KIT, WHICH WAS RETURNED UNSEALED, WAS VISUALLY INSPECTED FOR A MISSING ADAPTOR. RESULTS: A VISUAL INSPECTION REVEALED THAT THE OFFSET ADAPTOR WAS MISSING FROM THE BREATHING CIRCUIT KIT, CONFIRMING THE REPORTED FAULT. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 101208. CONCLUSION: THE BREATHING CIRCUIT PACKAGE CONSISTS OF A NUMBER OF COMPONENTS GROUPED TOGETHER DURING PRODUCTION. IT IS LIKELY THAT OPERATOR ERROR, DURING THE PACKING PROCESS, RESULTED IN THE MISSING OFFSET ADAPTOR. (B)(4). BREATHING CIRCUIT KITS ARE ALSO VISUALLY INSPECTED FOR MISSING COMPONENTS PRIOR TO DISTRIBUTION. (B)(4).

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT064 ADAPTER WAS MISSING FROM AN RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT KIT. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN RT064 ADAPTER WAS MISSING FROM AN RT329 INFANT CONTINUOUS FLOW BREATHING CIRCUIT KIT. THIS WAS NOTICED PRIOR TO PATIENT USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT CONTINUOUS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED RT329 101208

    Patients

    Seq Age Sex Outcome Treatment
    1