BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT VENTILATOR DUAL HEATED CIRCUIT KIT

    MDR report key: 9579464 · Received January 12, 2020

    Report

    Report Number
    9611451-2020-00050
    Event Type
    Malfunction
    Date Received
    January 12, 2020
    Report Date
    December 13, 2019
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE 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 THAT PRODUCT IS K122432. METHOD: THE COMPLAINT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS NOT RECEIVED AT FISHER & PAYKEL HEALTHCARE. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION AND PHOTOGRAPH PROVIDED BY THE CUSTOMER, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PHOTOPGRAH PROVIDED BY THE CUSTOMER CONFIRMED THAT THE ELBOW CONNECTOR OF EXPIRATORY LIMB OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT WAS CRACKED. CONCLUSION: WITHOUT THE COMPLAINT DEVICE, WE CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE REPORTED FAILURE MODE. 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 MET THE REQUIRED SPECIFICATIONS AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS WHICH ACCOMPANY THE 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT ILLUSTRATE STATE THE FOLLOWING: - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM BEFORE CONNECTING TO A PATIENT." - "CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE." THE USER INSTRUCTIONS ALSO WARN THE USER: "SET APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS TO MONITOR THERAPY DELIVERY." "DO NOT CLEAN OR STERILIZE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN AUSTRALIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE EXPIRATORY LIMB OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT WAS CRACKED. IT WAS REPORTED THAT THE HOSPITAL STAFF SUSPECTS THE DAMAGE OCCURRED WHILE CHANGING THE CIRCUIT, AFTER 7 DAYS OF USE, EITHER DURING EXTUBATING OR REINTUBATING THE PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE 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 THAT PRODUCT IS K122432. WE ARE CURRENTLY IN THE PROCESS OF INVESTIGATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE EXPIRATORY LIMB OF A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT WAS CRACKED. IT WAS REPORTED THAT THE HOSPITAL STAFF SUSPECTS THE DAMAGE OCCURRED WHILE CHANGING THE CIRCUIT, AFTER 7 DAYS OF USE, EITHER DURING EXTUBATING OR REINTUBATING THE PATIENT. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42681 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD 950A81 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1