BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 2863220 · Received December 10, 2012

    Report

    Report Number
    9611451-2012-00901
    Event Type
    Malfunction
    Date Received
    December 10, 2012
    Report Date
    November 8, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K034026. WE ARE CURRENTLY OBTAINING FURTHER INFORMATION FROM THE CUSTOMER REGARDING THIS COMPLAINT. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT265 INFANT EVAQUA2 BREATHING CIRCUIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K034026. THE COMPLAINT DEVICES ARE NOT EXPECTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE AS THEY ARE NO LONGER AVAILABLE. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. THE INSPIRATORY AND EXPIRATORY LIMBS OF THE COMPLAINT RT265 BREATHING CIRCUITS WERE REPORTED TO BE DISCONNECTING FROM THE Y-PIECE. THE PRESSURE LINE WAS ALSO REPORTED TO BE DISCONNECTING FROM THE VENTILATOR. THE HOSPITAL STATED THAT THE BREATHING CIRCUIT PASSED THE INITIAL LEAK TEST AND THE DISCONNECTION WAS OBSERVED AT DIFFERENT PERIODS OF TIME DURING USE. THE HOSPITAL WAS NOT CERTAIN IF ALL OF THE NURSES CHECKED THE TIGHTNESS OF THE CONNECTIONS BEFORE USE. AS THE COMPLAINT DEVICE WAS NOT RETURNED, WE WERE UNABLE TO DETERMINE THE CAUSE OF THE DISCONNECTION AND COULD NOT CONFIRM A FAULT FOR ANY PARTICULAR FAILURE MODE. IF THE COMPLAINT DEVICE WAS RETURNED, AN EVALUATION WOULD HAVE BEEN MADE TO DETERMINE IF THE DEVICE IS WITHIN SPECIFICATION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT265 DEVICE STATE THE FOLLOWING: "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE; PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT; SET APPROPRIATE VENTILATOR ALARMS."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE INSPIRATORY AND EXPIRATORY LIMBS OF 5 RT265 INFANT BREATHING CIRCUITS WERE DISCONNECTING FROM THE Y-PIECE. THE PRESSURE LINE WAS ALSO REPORTED TO BE DISCONNECTING FROM THE VENTILATOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(4) REPORTED THAT THE INSPIRATORY AND EXPIRATORY LIMBS OF 5 RT265 INFANT BREATHING CIRCUITS WERE DISCONNECTING FROM THE Y-PIECE. THE PRESSURE LINE WAS ALSO REPORTED TO BE DISCONNECTING FROM THE VENTILATOR. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD RT265 120515

    Patients

    Seq Age Sex Outcome Treatment
    1