BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 9772849 · Received March 1, 2020

    Report

    Report Number
    9611451-2020-00222
    Event Type
    Malfunction
    Date Received
    March 1, 2020
    Date of Event
    January 31, 2020
    Report Date
    February 3, 2020
    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 K103767. METHOD: TWO 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 THE TWO COMPLAINT PRESSURE LINES REVEALED A MOULDING DEFECT ON THE ELBOW OF PRESSURE LINE FOR BOTH DEVICES. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT CAUSED THE MOULDING DEFECT OF THE PRESSURE LINE ELBOW. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT268 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 DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE PRESSURE LINE OF TWO RT268 INFANT EVAQUA2 BREATHING CIRCUITS CAME 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 K103767. THE COMPLAINT RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS RECENTLY RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND. WE WILL SUBMIT A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE PRESSURE LINE OF TWO RT268 INFANT EVAQUA2 BREATHING CIRCUITS CAME OFF DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236363 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE RT268 2100856945

    Patients

    Seq Age Sex Outcome Treatment
    1