BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT BIAS FLOW BREATHING CIRCUIT

    MDR report key: 2155063 · Received July 8, 2011

    Report

    Report Number
    9611451-2011-00412
    Event Type
    Malfunction
    Date Received
    July 8, 2011
    Date of Event
    May 13, 2011
    Report Date
    June 9, 2011
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K): THE RT225 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THAT PRODUCT IS K20332. METHOD: TEN DEVICES (LOT 110322) WERE RECEIVED FOR EVALUATION, INCLUDING THE COMPLAINT DEVICE. ALL TEN DEVICES WERE VISUALLY INSPECTED, PERFORMANCE TESTED AND PRESSURE TESTED FOR LEAKS. RESULTS: THE VISUAL INSPECTION REVEALED NO PHYSICAL DAMAGE TO THE PRODUCTS. THE PRESSURE FOR ALL TEN DEVICES WERE FOUND TO BE WITHIN SPECIFICATION FOR THE DEVICE. THE HEATER WIRE SOCKET OF ALL DEVICES WERE ABLE TO BE ROTATED AS OBSERVED BY THE CUSTOMER. CONCLUSION: THE HEATER WIRE SOCKET IS DESIGNED TO ROTATE IN THE CHAMBER ELBOW WITH A HEATER WIRE ADAPTOR FITTED AND AS SUCH IS NOT A DEFECT. NO FAULT WAS FOUND WITH ANY OF THE COMPLAINT DEVICES. IT IS POSSIBLE THE SMALL AMOUNT OF WATER LEAKAGE OBSERVED BY THE CUSTOMER IS DUE TO THE PRESENCE OF CONDENSATION. ALL BREATHING CIRCUITS ARE PRESSURE TESTED DURING PRODUCTION LINE, BEFORE THEY LEAVE THE FACTORY. ANY BREATHING CIRCUITS THAT FAIL ARE DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT225 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IS SIMILAR TO A PRODUCT WHICH SOLD IN THE USA. THE 510(K) NUMBER OF THAT PRODUCT IS K20332. WE HAVE RECENTLY RECEIVED THE COMPLAINT DEVICES AND EVALUATION IS ANTICIPATED. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE "HEATER MODULE" IN THE ELBOW OF THE INSPIRATORY LIMB OF TEN RT225 INFANT BIAS FLOW BREATHING CIRCUIT ROTATED DURING USE AND THAT THERE WAS A LITTLE WATER LEAKAGE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA OUR DISTRIBUTOR THAT THE "HEATER MODULE" IN THE ELBOW OF THE INSPIRATORY LIMB OF AN RT225 INFANT BIAS FLOW BREATHING CIRCUIT ROTATED DURING USE AND THAT THERE WAS A LITTLE WATER LEAKAGE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT BIAS FLOW BREATHING CIRCUIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD RT225 110322

    Patients

    Seq Age Sex Outcome Treatment
    1 NEWPORT E-100 VENTILATOR| NEWPORT E-100 VENTILATOR