BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 21694492 · Received March 25, 2025

    Report

    Report Number
    9611451-2025-00252
    Event Type
    Malfunction
    Date Received
    March 25, 2025
    Date of Event
    February 17, 2025
    Report Date
    August 29, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    UDI-DI
    09420012458223
    PMA / PMN Number
    SEE H11
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE RT269 INFANT EVAQUA2 BREATHING CIRCUIT FOR SLE6000 SERIES VENTILATORS IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K103767. SECTION H11: METHOD: THE SUBJECT RT269 INFANT EVAQUA2 BREATHING CIRCUIT FOR SLE6000 SERIES VENTILATORS WAS RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. RESULTS: VISUAL INSPECTION OF THE RETURNED DEVICE IDENTIFIED DAMAGE ON THE EXPIRATORY LIMB OF THE SUBJECT RT269 BREATHING CIRCUIT, CONFIRMING THE REPORTED EVENT. CONCLUSION: THE REPORTED DAMAGE WAS CONFIRMED, AND WAS MOST LIKELY CAUSED BY A SHARP OBJECT. ALL RT269 INFANT EVAQUA2 BREATHING CIRCUITS FOR SLE6000 SERIES VENTILATORS ARE VISUALLY INSPECTED, AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT269 INFANT EVAQUA2 BREATHING CIRCUIT FOR SLE6000 SERIES VENTILATORS STATES THE FOLLOWING: - VISUALLY INSPECT BREATHING SETS FOR DAMAGE (E.G. CRUSHED TUBE OR CRACKED CONNECTOR) BEFORE USE AND REPLACE IF DAMAGED. - 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. - APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: THE RT269 INFANT EVAQUA2 BREATHING CIRCUIT FOR SLE6000 SERIES VENTILATORS IS NOT SOLD IN THE USA, BUT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K103767. THE SUBJECT RT269 INFANT EVAQUA2 BREATHING CIRCUIT FOR SLE6000 SERIES VENTILATORS HAS BEEN REQUESTED TO BE RETURNED TO FISHER & PAYKEL (F&P) HEALTHCARE IN NEW ZEALAND FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN SINGAPORE THAT AN RT269 INFANT EVAQUA2 BREATHING CIRCUIT FOR SLE6000 SERIES VENTILATORS WAS FOUND LEAKING AIR FROM A HOLE ON THE EXPIRATORY LIMB BEFORE PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN SINGAPORE THAT AN RT269 INFANT EVAQUA2 BREATHING CIRCUIT FOR SLE6000 SERIES VENTILATORS WAS FOUND LEAKING AIR FROM A HOLE ON THE EXPIRATORY LIMB BEFORE PATIENT USE. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694987 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BZE FISHER & PAYKEL HEALTHCARE LTD RT269 2103379097 09420012458223

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown