BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24812184 · Received April 7, 2026

    Report

    Report Number
    9611451-2026-01256
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Report Date
    April 8, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    UDI-DI
    09420012436825
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    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. 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.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN GERMANY REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS DAMAGED AND LEAKING AIR DURING PATIENT USE. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313049 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD 950A81 2104012001 09420012436825

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown DRÄGER EVITA V800 VENTILATOR.| F&P 950 RESPIRATORY HUMIDIFIER.