BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVAQUA INFANT BREATHING CIRCUIT

    MDR report key: 1035698 · Received April 24, 2008

    Report

    Report Number
    9611451-2008-00205
    Event Type
    Malfunction
    Date Received
    April 24, 2008
    Date of Event
    February 18, 2008
    Report Date
    February 18, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BZE
    PMA / PMN Number
    K034026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OTHER LOT NUMBERS INVOLVED ARE: 070906, 070731, 070702 AND 070810. DEVICE MANUFACTURE DATES: 09/16/2007, 07/31/2007, 07/08/2007, 08/10/2007 AND 05/22/2007. THE CIRCUITS WERE PRESSURE TESTED. RESULTS: LEAKS WERE FOUND ON SIX OF THE SEVEN SAMPLES. ON TWO OF THE SAMPLES, A CRACK WAS FOUND ON THE SWIVEL Y-PIECE. FOR THE REMAINDER OF THE SAMPLES, THE LEAK WAS LOCATED SOMEWHERE ON THE SWIVEL Y-PIECE. IT WAS NOTED THAT REPOSITIONING THE Y-PIECE WITH RESPECT TO THE ELBOW COULD REDUCE THE LEAKING SIGNIFICANTLY. CONCLUSION: OUR MONITORING AND TRENDING FOR THIS TYPE OF EVENT HAS A RATE OF OCCURRENCE WORLDWIDE FOR THE LAST YEAR OF 0.0036%. THE BREATHING CIRCUIT IS PRESSURE TESTED DURING PRODUCTION AND UNITS THAT FAIL ARE REJECTED. THE UNIT DOES HAVE A SMALL AMOUNT OF ACCEPTABLE LEAK. DURING SETUP, ROTATION OF THE SWIVEL HAS CAUSED THE LEAK TO INCREASE UNACCEPTABLY.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY REPORTED TO OUR DISTRIBUTOR THAT SEVEN RT235 EVAQUA INFANT BREATHING CIRCUITS DID NOT PASS THE VENTILATOR LEAK TEST. NO PT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVAQUA INFANT BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE, LTD. RT235 070522

    Patients

    Seq Age Sex Outcome Treatment
    1 VENTILATOR