BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 20186691 · Received September 10, 2024

    Report

    Report Number
    9611451-2024-00659
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    August 26, 2024
    Report Date
    August 27, 2024
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    UDI-DI
    09420012458223
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE RT269 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: THE SUBJECT RT269 BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS THEREFORE BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE PRESSURE LINE OF THE RT269 BREATHING CIRCUIT WAS FOUND DISCONNECTED DURING PATIENT USE. THE HEALTHCARE FACILITY FURTHER CONFIRMED THAT THERE WAS NO MALFUNCTION OBSERVED WITH THE SUBJECT BREATHING CIRCUIT AND ITS PRESSURE LINE. IT WAS REPORTED THAT THE DISCONNECTION OCCURRED DUE TO USE ERROR DURING SETUP OF THE DEVICE. CONCLUSION: THE REPORTED DISCONNECTION OF THE PRESSURE LINE WAS DUE TO USE ERROR DURING DEVICE SETUP. ALL RT269 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT269 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." "ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT."

    Additional Manufacturer Narrative · 0

    (B)(4) SECTION G4: THE RT269 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 SUBJECT RT269 INFANT BREATHING CIRCUIT HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL HEALTHCARE NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN ITALY REPORTED THAT THE PRESSURE LINE OF A RT269 INFANT EVAQUA2 BREATHING CIRCUIT DISCONNECTED DURING PATIENT USE. THE HEALTHCARE FACILITY LATER INDICATED THAT THE DEFECT WAS MOST LIKELY DUE TO USE ERROR. THERE WAS NO PATIENT CONSEQUENCE.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN ITALY REPORTED THAT THE PRESSURE LINE OF A RT269 INFANT EVAQUA2 BREATHING CIRCUIT DISCONNECTED DURING PATIENT USE. THE HEALTHCARE FACILITY LATER INDICATED THAT THE DEFECT WAS MOST LIKELY DUE TO USE ERROR. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563006 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT269 2102851556 09420012458223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown