BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 10419502 · Received August 18, 2020

    Report

    Report Number
    9611451-2020-00707
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Report Date
    July 20, 2020
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE 1 AND 2 LOT NUMBER: 190114, DOM: 14 JANUARY 2019. DEVICE 3 LOT NUMBER: 191205, DOM: 5 DECEMBER 2019. DEVICE 4 LOT NUMBER: 200212, DOM: 12 FEBRUARY 2020. METHOD: THE FOUR COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND WHERE THEY WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION REVEALED A CRACK ON THE BOTTOM OF THE CHAMBER DOMES. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE CHAMBER DOMES TO CRACK. EVERY MR290V CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. ALSO, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. THE SUBJECT MR290V CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. THE USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIFICIATION CHAMBER STATE THE FOLLOWING: "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." "SET APPROPRIATE VENTILATOR ALARM." "PERFORM 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 HONG KONG REPORTED THAT FOUR MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE CRACKED AND LEAKED WATER BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE IN PROCESS OF OBTAINING THE COMPLAINT MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS FROM THE CUSTOMER 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 THAT FOUR MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE CRACKED AND LEAKED WATER BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883032 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1