BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 9573279 · Received January 9, 2020

    Report

    Report Number
    9611451-2020-00044
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    December 11, 2019
    Report Date
    December 13, 2019
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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: SIX PRESSURE LINES OF RT268 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR EVALUATION AND WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF PRESSURE LINES REVEALED THAT A MOULDING DEFECT WAS FOUND ON THE ELBOW OF PRESSURE LINES. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE MOULDING DEFECT OF THE PRESSURE LINE ELBOW. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT265 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT STATES: "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 JAPAN REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE PRESSURE LINE OF AN RT268 INFANT EVAQUA2 BREATHING CIRCUIT FALLS OFF DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    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 RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT IS CURRENTLY EN ROUTE TO FISHSER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION TO DETERMINE IF IT HAD A MALFUNCTION, WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE COMPLETED OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE THAT THE PRESSURE LINE OF AN RT268 INFANT EVAQUA2 BREATHING CIRCUIT FALLS OFF DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35956 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE RT268 2100856945

    Patients

    Seq Age Sex Outcome Treatment
    1