BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAMBER COMPLETE AUTOFEED 900

    MDR report key: 11936307 · Received June 3, 2021

    Report

    Report Number
    9611451-2021-00644
    Event Type
    Malfunction
    Date Received
    June 3, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 7, 2021
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBER 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 K934140. METHOD: THE COMPLAINT Z41002 CHAMBER WAS RECEIVED AT FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND WHERE IT WAS VISUALLY INSPECTED AND ANALYSED. RESULTS: VISUAL INSPECTION CONFIRMED THAT CRACK LINE WAS FOUND ON THE BASE OF THE CHAMBER DOME. THE ROLLED BASE THICKNESS WAS FOUND TO BE WITHIN SPECIFICATION. FURTHER ANALYSIS OF THE SUBJECT Z41002 CHAMBER REVEALED SIGNS OF ENVIRONMENTAL STRESS CRACKING (ESC) WHICH INDICATES EXPOSURE TO CHEMICAL ATTACK. CONCLUSION: WE ARE UNABLE TO DETERMINE THE CAUSE OF THE REPORTED EVENT. HOWEVER, IT IS LIKELY THAT THIS WAS CAUSED BY EXPOSURE TO CHEMICAL WHICH IS INCOMPATIBLE WITH CHAMBER DOME MATERIAL. EVERY Z41002 CHAMBER COMPLETE AUTOFEED 900 IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DOME DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. NO CRACKS IN THE CHAMBER DOME ARE ACCEPTABLE. ANY CHAMBER THAT FAILS THIS INSPECTION IS REJECTED. THE SUBJECT CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE Z41002 CHAMBER COMPLETE AUTOFEED 900 STATE THE FOLLOWING: - "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." - "DO NOT USE BEYOND 14 DAYS MAXIMUM DURATION OF USE." - "SET APPROPRIATE VENTILATOR ALARMS." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN SWEDEN REPORTED VIA A FISHER AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBER FROM 950A81 VENTED DUAL HEATED CIRCUIT KIT WAS LEAKING WATER BETWEEN THE CHAMBER BASE AND CHAMBER DOME. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBER 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 K934140. THE COMPLAINT Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (F&P) 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 AND PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT A Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBER FROM 950A81 VENTED DUAL HEATED CIRCUIT KIT WAS LEAKING WATER BETWEEN THE CHAMBER BASE AND CHAMBER DOME. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    831791 CHAMBER COMPLETE AUTOFEED 900 BTT BTT Z41002 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 F&P 950 RESPIRATORY HUMIDIFIER| F&P 950 RESPIRATORY HUMIDIFIER| F&P 950A81 ADULT BREATHING CIRCUIT| F&P 950A81 ADULT BREATHING CIRCUIT