BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 25250254 · Received May 21, 2026

    Report

    Report Number
    9611451-2026-01738
    Event Type
    Malfunction
    Date Received
    May 21, 2026
    Date of Event
    April 30, 2026
    Report Date
    May 22, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION D4: COMPLETE DEVICE IDENTIFICATION INFORMATION WAS NOT PROVIDED. 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. SECTION H4: COMPLETE DEVICE IDENTIFICATION INFORMATION WAS NOT PROVIDED. FISHER & PAYKEL (F&P) HEALTHCARE IS IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN SPAIN REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE THAT TWO 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WERE FOUND BROKEN DURING USE. THERE WAS NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95996 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD 950A81

    Patients

    Seq Age Sex Outcome Treatment
    1