BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BZE

    MDR report key: 979008 · Received January 16, 2008

    Report

    Report Number
    9611451-2008-00006
    Event Type
    Malfunction
    Date Received
    January 16, 2008
    Date of Event
    December 17, 2007
    Report Date
    December 17, 2007
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    PMA / PMN Number
    K983112
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICES WERE VISUALLY INSPECTED. RESULTS: WHEN INSPECTING THE RT240 BREATHING CIRCUIT Y CONNECTORS, IT WAS CONFIRMED THAT THE INNER TAPERED TUBE CONNECTION HAD BROKEN OFF. THE OUTER TUBE CONNECTION WAS INTACT. THE Y-PIECE CONNECTORS WERE MOULDED IN CAVITY 4 OF THE MOULD TOOL. OUR RECORDS INDICATE THAT THIS IS THE ONLY COMPLAINT OF THIS NATURE RECEIVED FOR THE GIVEN LOT NUMBER. CONCLUSIONS: THE INNER TAPERED TUBE CONNECTION HAS ADHERED TO THE MOULD TOOL DURING EJECTION OF THE PART AND BROKEN OFF. THIS FAULT IS USUALLY RECOGNIZED BY THE OPERATOR AND ALL THE AFFECTED PARTS ARE REJECTED. AT THIS POINT, MAINTENANCE OF THE TOOL IS CARRIED OUT TO RECTIFY THE PROBLEM. THE DEVICE WAS OUT OF SPECIFICATION. THIS WILL BE BROUGHT TO THE ATTENTION OF MANUFACTURING TEAM MEMBERS. NO FURTHER INVESTIGATION WILL BE CONDUCTED ON THIS COMPLAINT.

    Description of Event or Problem · 1

    A HOSPITAL REPORTED TO OUR DISTRIBUTOR THAT 2 X RT240 ADULT BREATHING CIRCUIT Y CONNECTORS HAD THE PLASTIC "INNER RING MISSING" THAT ALLOWS PATIENT INTERFACE CONNECTION. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BZE BZE FISHER & PAYKEL HEALTHCARE, LTD. RT240 070910

    Patients

    Seq Age Sex Outcome Treatment
    1 DRAGER VENTILATOR