BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 24960135 · Received April 22, 2026

    Report

    Report Number
    9611451-2026-01401
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 23, 2026
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION D4: COMPLETE DEVICE IDENTIFICATION INFORMATION WAS NOT PROVIDED. SECTION G4: 950N81 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 CURRENTLY 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 NORWAY REPORTED VIA A FISHER & PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT THE DRY LINE TUBING AND THE EXPIRATORY TUBING OF AN F&P 950N81 NEONATAL VENTILATOR DUAL HEATED CIRCUIT KIT WERE INCORRECTLY CONNECTED IN REVERSE TO THE VENTILATOR (NON-F&P HEALTHCARE PRODUCT). THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT BECAME HYPOTHERMIC, AND THERAPY WAS STOPPED. F&P HEALTHCARE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION REGARDING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451406 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD 950N81

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown AERONEB SOLO.| F&P 950AEU RESPIRATORY HUMIDIFIER.| MAQUET SERVO-N.| STEPHAN HEADGEAR.