BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAMBER COMPLETE AUTOFEED 900

    MDR report key: 11780395 · Received May 5, 2021

    Report

    Report Number
    9611451-2021-00520
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Report Date
    April 7, 2021
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 CHAMBERS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. OUR INVESTIGATION IS THUS BASED ON THE INFORMATION AND PHOTOGRAPH PROVIDED BY THE CUSTOMER, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE CUSTOMER REPORTED THAT THREE Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBERS FROM 950A81 VENTED DUAL HEATED CIRCUIT KITS WERE LEAKING. CONCLUSION: WITHOUT THE COMPLAINT DEVICES, WE ARE UNABLE TO CONFIRM THE REPORTED EVENTS. FURTHER TRAINING ON DEVICE SET-UP WAS PROVIDED. 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 THE UK REPORTED THAT THREE Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBERS WERE LEAKING. IT WAS ALSO NOTED THAT FLOLAN WAS ADMINISTERED AS A NEBULIZED DRUG. 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 CHAMBERS ARE 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 THE (B)(6) REPORTED THAT THREE Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBERS WERE LEAKING. IT WAS ALSO NOTED THAT FLOLAN WAS ADMINISTERED AS A NEBULIZED DRUG. THERE WAS NO REPORTED PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675539 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