BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FISHER & PAYKEL HEALTHCARE

    MDR report key: 21430572 · Received February 21, 2025

    Report

    Report Number
    9611451-2025-00163
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Report Date
    January 22, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K220703
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). SECTION G4: PMA/510(K) NUMBER - THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT INSTEAD A SIMILAR PRODUCT: 950A81J ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K220703. FISHER & PAYKEL HEALTHCARE (F&P) IS CURRENTLY IN THE PROCESS OF COMPLETING OUR INVESTIGATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). SECTION G4: PMA/510(K) NUMBER - THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) IS NOT SOLD IN THE UNITED STATES OF AMERICA (USA) BUT INSTEAD A SIMILAR PRODUCT, 950A81J ADULT VENTILATOR DUAL HEATED CIRCUIT KIT (WITH FILTER) IS SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K220703. METHOD: THE COMPLAINT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR INVESTIGATION, WHERE IT WAS VISUALLY INSPECTED, AND EXAMINED USING FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR). RESULTS: VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED THAT THERE WERE EXTENSIVE SIGNS OF ABRASION. THE FTIR ANALYSIS SHOWED NO INDICATION OF DEGRADATION OF THE TUBE MATERIAL. CONCLUSION: THE CRACKING OF THE EXPIRATORY LIMB COULD HAVE OCCURRED DUE TO AN EXTERNALLY APPLIED MECHANICAL FORCE. HOWEVER, WE ARE UNABLE TO DETERMINE THE SOURCE OF THE MECHANICAL FORCE. ALL 950A81 ADULT VENTILATOR DUAL HEATED BREATHING CIRCUITS ARE 100% LEAK TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. THE SUBJECT 950A81 BREATHING CIRCUIT WOULD HAVE MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE 950A81 ADULT VENTED DUAL HEATED CIRCUIT KIT STATE THE FOLLOWING: -APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH. -SINGLE USE. DO NOT REUSE THIS PRODUCT. REUSE MAY RESULT IN TRANSMISSION OF INFECTIOUS SUBSTANCES, INTERRUPTION TO TREATMENT, SERIOUS HARM, OR DEATH. -DO NOT CRUSH, STRETCH, OR MILK THE TUBING. -DO NOT CLEAN OR STERILIZE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS. -PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT -CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN AUSTRALIA HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE EXPIRATORY LIMB OF THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT HAS A HOLE AND FAILED THE PREUSE TESTS. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN AUSTRALIA HAS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE EXPIRATORY LIMB OF THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT HAS A HOLE AND FAILED THE PREUSE TESTS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1269299 FISHER & PAYKEL HEALTHCARE BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD 950A81

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown