BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT OPTIFLOW? TUBING KIT

    MDR report key: 4338063 · Received December 17, 2014

    Report

    Report Number
    9611451-2014-00934
    Event Type
    Malfunction
    Date Received
    December 17, 2014
    Date of Event
    November 18, 2014
    Report Date
    November 19, 2014
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K020332
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT RT330 INFANT OPTIFLOW CIRCUIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE HEATER WIRE SOCKET WAS REMOVED FROM THE TUBE AND THE HEATER WIRE WAS CUT AS NEAR AS POSSIBLE TO THE SOCKET. THE ELECTRICAL RESISTANCE OF THE HEATER WIRE WAS TESTED USING A CALIBRATED MULTIMETER AND EACH HEATER WIRE SOCKET PIN WAS CONTINUITY TESTED. RESULTS: THE ELECTRICAL RESISTANCE TEST SHOWED THAT THE HEATER WIRE WAS WITHIN SPECIFICATION. THE CONTINUITY TEST OF THE HEATER WIRE SOCKET PINS REVEALED THAT THERE WAS A BREAK BETWEEN THE HEATER WIRE AND THE LEFT HEATER WIRE PIN. THIS WAS OUT OF SPECIFICATION. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 140507. CONCLUSION: THE FAILURE MODE WAS DETERMINED TO BE A BREAK IN THE CONNECTION BETWEEN THE HEATER WIRE AND THE HEATER WIRE PIN. THE FAULT OBSERVED CAN BE ASSOCIATED WITH INSUFFICIENT CONNECTION BETWEEN THE HEATER WIRE AND THE HEATER PINS, SUCH THAT IT IS UNABLE TO PROVIDE CONTINUITY FOR THE FULL PERIOD OF USE FOR THE PRODUCT. ALL BREATHING CIRCUITS ARE TESTED FOR CONNECTIVITY AND ELECTRICAL CONTINUITY DURING PRODUCTION AND THOSE THAT FAIL ARE REJECTED. THIS SUGGESTS THAT THE DEVICE BECAME OPEN CIRCUIT AFTER BEING RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT330 OPTIFLOW JUNIOR TUBING KIT ILLUSTRATE THE CORRECT SET-UP AND ALSO STATE THE FOLLOWING: - CHECK THAT ALL CONNECTIONS, CAPS AND/OR PLUGS ARE TIGHT BEFORE USE. - PATIENT MONITORING IS RECOMMENDED. (B)(4).

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING SETUP OF AN RT330 INFANT OPTIFLOW CIRCUIT THE DEVICE DID NOT DELIVER HUMIDIFIED GAS. THIS OCCURRED PRIOR TO PATIENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829074 INFANT OPTIFLOW? TUBING KIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT330 140507

    Patients

    Seq Age Sex Outcome Treatment
    1