BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT VENTILATOR DUAL HEATED CIRCUIT KIT

    MDR report key: 8942916 · Received August 28, 2019

    Report

    Report Number
    9611451-2019-00827
    Event Type
    Malfunction
    Date Received
    August 28, 2019
    Report Date
    July 30, 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 KITS WERE RECEIVED AT FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND WHERE THEY WERE VISUALLY INSPECTED AND LEAK TESTED. RESULTS: VISUAL INSPECTION FOUND NO SIGNS OF DAMAGE TO THE COMPLAINT DEVICES RETURNED FOR INVESTIGATION. A LEAK TEST WAS PERFORMED AND IT WAS FOUND THAT ONE OF THE BREATHING CIRCUITS HAD NO FAULT WHILE THE OTHER HAD A GAS LEAK AROUND THE T SEAL RING OF THE INSPIRATORY CONNECTOR. CONCLUSION: THE FAULTY BREATHING CIRCUIT WAS FOUND TO HAVE A SEAL RING FLIPPED OVER ON THE TUBING CAUSING THE GAS LEAK. HOWEVER, WE WERE UNABLE TO DETERMINE CONCLUSIVELY 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 AUSTRALIA REPORTED, VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE, THAT THE INSPIRATORY LIMBS OF TWO 950A81 ADULT VENTILATOR HEATED CIRCUIT KITS HAD FAILED THE PRESSURE TEST DUE TO AIR LEAK DURING SETUP. 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 THE INSPIRATORY LIMBS OF TWO 950A81 ADULT VENTILATOR HEATED CIRCUIT KITS HAD FAILED THE PRESSURE TEST DUE TO AIR LEAK DURING SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732647 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT BZE BZE FISHER & PAYKEL HEALTHCARE LTD 950A81 2100789210

    Patients

    Seq Age Sex Outcome Treatment
    1 SERVO U AND PB VENTILATORS