BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 8402492 · Received March 7, 2019

    Report

    Report Number
    9611451-2019-00190
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Report Date
    February 6, 2019
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BZE
    PMA / PMN Number
    SEE H.10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE RT268 INFANT DUAL-HEATED 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. METHOD: THE COMPLAINT RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND FOR EVALUATION. OUR ANALYSIS IS ACCORDINGLY BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL AND OUR KNOWLEDGE OF THE DEVICE. RESULTS: THE HOSPITAL REPORTED THAT THE PRESSURE LINE OF AN RT268 INFANT EVAQUA2 BREATHING CIRCUIT IS "FALLING OUT OF THE VENTILATOR CIRCUIT". CONCLUSION: BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL AND WITHOUT THE COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE THE CAUSE OF THE ALLEGED MALFUNCTION. EACH PRESSURE LINE OF RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT IS VISUALLY INSPECTED BEFORE LEAVING THE PRODUCTION LINE, ENSURING THAT THE PRESSURE LINE ADAPTOR IS FULLY INSERTED INTO THE PRESSURE LINE. THOSE THAT FAIL ARE REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT 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 · 0

    A HEALTHCARE FACILITY IN AUSTRALIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE PRESSURE LINE OF AN RT268 INFANT EVAQUA2 BREATHING CIRCUIT IS "FALLING OUT OF THE VENTILATOR CIRCUIT". THERE WAS NO REPORTED PATIENT HARM.

    Additional Manufacturer Narrative · 1

    (B)(4). THE RT268 INFANT DUAL-HEATED 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 DEVICE IS EXPECTED BUT HAS NOT YET BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE PRESSURE LINE OF AN RT268 INFANT EVAQUA2 BREATHING CIRCUIT IS "FALLING OUT OF THE VENTILATOR CIRCUIT". THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194929 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE FISHER & PAYKEL HEALTHCARE LIMITED RT268 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 SLE 6000 INFANT VENTILATOR