BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT VENTILATOR DUAL HEATED CIRCUIT KIT

    MDR report key: 10945312 · Received December 4, 2020

    Report

    Report Number
    9611451-2020-01097
    Event Type
    Malfunction
    Date Received
    December 4, 2020
    Report Date
    November 5, 2020
    Product Code
    BZE
    UDI-DI
    09420012436825
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    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 RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) NEW ZEALAND FOR INVESTIGATION WHERE IT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: THE LEAK TEST REVEALED THAT THE BREATHING CIRCUIT WAS OUT OF SPECIFICATION. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. 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 GERMANY REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT FAILED THE LEAK TEST DURING DEVICE 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. THE COMPLAINT 950A81 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(6) FOR EVALUATION. 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 DUAL HEATED CIRCUIT KIT FAILED THE LEAK TEST DURING DEVICE SETUP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1415118 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT BZE BZE 950A81 2101134237 09420012436825

    Patients

    Seq Age Sex Outcome Treatment
    1 DRAEGER V600 VENTILATOR| DRAEGER V600 VENTILATOR| F&P 950 RESPIRATORY HUMIDIFIER| F&P 950 RESPIRATORY HUMIDIFIER