BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT

    MDR report key: 11467680 · Received March 11, 2021

    Report

    Report Number
    9611451-2021-00281
    Event Type
    Malfunction
    Date Received
    March 11, 2021
    Date of Event
    February 11, 2021
    Report Date
    February 11, 2021
    Product Code
    BZE
    UDI-DI
    09420012431158
    PMA / PMN Number
    K103767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PS362455 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. SECTION B5 WAS CORRECTED. METHOD: THE COMPLAINT RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR INVESTIGATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE CUSTOMER REPORTED THAT THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT DID NOT PASS THE VENTILATOR TEST. CONCLUSION: WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. ALL RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT INFANT BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. 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 DISTRIBUTOR IN COLOMBIA REPORTED ON BEHALF OF A HEALTHCARE FACILITY VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT DID NOT PASS THE VENTILATOR TEST. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    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. WE ARE CURRENTLY IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION FROM THE CUSTOMER FOR EVALUATION. WE WILL PROVIDE 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 RT268 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT DID NOT PASS THE VENTILATOR TEST DURING USE. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365250 INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE BZE RT268 2100456807 09420012431158

    Patients

    Seq Age Sex Outcome Treatment
    1