BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT VENTILATOR DUAL HEATED CIRCUIT KIT

    MDR report key: 9608188 · Received January 20, 2020

    Report

    Report Number
    9611451-2020-00054
    Event Type
    Malfunction
    Date Received
    January 20, 2020
    Date of Event
    September 20, 2019
    Report Date
    September 23, 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
    003

    Narratives

    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. 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 PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: CUSTOMER REPORTED THAT A LEAK WAS OBSERVED TO A COMPONENT OF THE CIRCUIT. 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."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A LEAK WAS OBSERVED FROM A COMPONENT OF THE 950A81 ADULT VENTILATOR HEATED CIRCUIT KIT. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71847 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD 950A81 2100801718

    Patients

    Seq Age Sex Outcome Treatment
    1