BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24016307 · Received January 8, 2026

    Report

    Report Number
    9611451-2026-00109
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Report Date
    February 11, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K220703. FISHER & PAYKEL (F&P) HEALTHCARE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION REGARDING THE REPORTED EVENT. WE HAVE ALSO REQUESTED THE RETURN OF THE SUBJECT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT TO F&P HEALTHCARE NEW ZEALAND FOR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION G4: 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT WHICH IS SOLD IN THE USA. THE 510(K) FOR THE SIMILAR PRODUCT IS K220703. METHOD: THE SUBJECT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS NOT RETURNED FISHER & PAYKEL (F&P) HEALTHCARE FOR EVALUATION AS THE CIRCUIT WAS DISCARDED. F&P HEALTHCARE REQUESTED FOR FURTHER INFORMATION FROM THE HEALTHCARE FACILITY, INCLUDING THE SEQUENCE OF EVENTS AND PHOTOGRAPHS. HOWEVER, NO PHOTOGRAPHS AND LIMITED INFORMATION WAS PROVIDED. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT THE 950A81 BREATHING CIRCUIT WAS LEAKING AIR DURING PATIENT USE. THE HEALTHCARE FACILITY FURTHER REPORTED THAT THEY IDENTIFIED A CRACK ON THE INSPIRATORY LIMB OF THE SUBJECT DEVICE. CONCLUSION: WITHOUT THE RETURN OF THE SUBJECT DEVICE, OR PHOTOGRAPHS TO CONFIRM THE REPORTED ISSUE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED ISSUE. THE USER INSTRUCTIONS THAT ACCOMPANY THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT STATE THE FOLLOWING: - PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT. - SET APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS TO MONITOR THERAPY DELIVERY - APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. - CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD, REPRESENTATIVE THAT THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS LEAKING AIR, DURING PATIENT USE. UPON INSPECTION, THE HEALTHCARE FACILITY IDENTIFIED A CRACK ON THE INSPIRATORY LIMB OF THE DEVICE. THERE WAS NO REPORTED PATIENT HARM.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN FRANCE REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS LEAKING AIR DURING PATIENT USE. UPON INSPECTION, THE HEALTHCARE FACILITY IDENTIFIED A CRACK ON THE INSPIRATORY LIMB OF THE DEVICE. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77993 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD 950A81

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown