BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT VENTILATOR DUAL HEATED CIRCUIT KIT

    MDR report key: 9319506 · Received November 13, 2019

    Report

    Report Number
    9611451-2019-01103
    Event Type
    Malfunction
    Date Received
    November 13, 2019
    Report Date
    October 15, 2019
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BZE
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 FOR 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED AND LEAK TESTED. RESULTS: VISUAL INSPECTION FOUND NO SIGNS OF DAMAGE TO THE COMPLAINT DEVICE RETURNED FOR INVESTIGATION. A LEAK TEST WAS PERFORMED AND IT WAS FOUND THAT THE BREATHING CIRCUIT HAD A GAS LEAK AROUND THE SEAL RING OF THE INSPIRATORY CONNECTOR. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED FAILURE MODE AT THIS STAGE. 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 · 0

    A HEALTHCARE FACILITY IN NEW ZEALAND REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT A 950A81 ADULT VENTILATOR HEATED CIRCUIT KIT HAD FAILED THE VENTILATOR LEAK TEST DURING SETUP, AS OUTLINED IN THE USER INSTRUCTIONS THAT ACCOMPANY THE 950A81. THERE WAS NO PATIENT INVOLVEMENT.

    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 A 950A81 ADULT VENTILATOR HEATED CIRCUIT KIT HAD FAILED THE LEAK TEST DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1108205 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD 950A81 2100884269

    Patients

    Seq Age Sex Outcome Treatment
    1