BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT VENTILATOR DUAL HEATED CIRCUIT KIT

    MDR report key: 10519201 · Received September 10, 2020

    Report

    Report Number
    9611451-2020-00779
    Event Type
    Malfunction
    Date Received
    September 10, 2020
    Report Date
    August 18, 2020
    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 RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR INVESTIGATION, WHERE IT WAS VISUALLY INSPECTED AND PRESSURE TESTED. RESULTS: VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEALED NO SIGNS OF DAMAGE. THE PRESSURE TEST ALSO REVEALED THAT THE BREATHING CIRCUIT WAS WITHIN SPECIFICATION. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE LEAK ALARM AS REPORTED BY THE CUSTOMER, AS NO FAULT WAS FOUND WITH THE RETURNED DEVICE. 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 WOULD HAVE 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 DISTRIBUTOR IN AUSTRALIA 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 IN TRANSIT TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION ON OUR INVESTIGATION.

    Description of Event or Problem · 1

    A DISTRIBUTOR IN (B)(4) 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
    983534 ADULT VENTILATOR DUAL HEATED CIRCUIT KIT BZE BZE 950A81 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1