BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CHAMBER COMPLETE AUTOFEED 900

    MDR report key: 11283484 · Received February 4, 2021

    Report

    Report Number
    9611451-2021-00124
    Event Type
    Malfunction
    Date Received
    February 4, 2021
    Report Date
    January 8, 2021
    Product Code
    BTT
    UDI-DI
    09420012455833
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE 1: BN 2101089221 DEVICE 2 AND 3: BN UNKNOWN THE Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBERS 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 COMPLETE AUTOFEED 900 CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR EVALUATION. THE COMPLAINT CHAMBERS WERE VISUALLY INSPECTED BY A TRAINED F&P TECHNICIAN. RESULTS: VISUAL INSPECTION OF THE RETURNED COMPLAINT MR290 CHAMBER REVEALED PHYSICAL DAMAGE TO THE BASE AND DOME OF THE CHAMBER. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT CAUSED THE REPORTED FAULT. 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 MR290V CHAMBER 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 AUSTRALIA REPORTED VIA A FISHER & PAYKEL HEALTHCARE(F&P) FIELD REPRESENTATIVE THAT THREE Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBERS WERE LEAKING. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBERS ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE(F&P) (B)(4) 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 THREE Z41002 CHAMBER COMPLETE AUTOFEED 900 CHAMBERS WERE LEAKING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179452 CHAMBER COMPLETE AUTOFEED 900 BTT BTT Z41002 2101089221 09420012455833

    Patients

    Seq Age Sex Outcome Treatment
    1 F&P 950 RESPIRATORY HUMIDIFIER| F&P 950 RESPIRATORY HUMIDIFIER| F&P AA451 OPTIFLOW THRIVE CIRCUIT KIT| F&P AA451 OPTIFLOW THRIVE CIRCUIT KIT