BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 10073501 · Received May 20, 2020

    Report

    Report Number
    9611451-2020-00485
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    April 16, 2020
    Report Date
    April 21, 2020
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LOT NUMBER 191023 (1 UNIT), LOT NUMBER 190809 (3 UNITS). METHOD: THE COMPLAINT MR290V HUMIDIFICATION CHAMBERS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION. THE INVESTIGATION IS THUS BASED ON THE PHOTOGRAPHY AND INFORMATION PROVIDED BY THE CUSTOMER, AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: VISUAL INSPECTION OF THE PHOTOGRAPHY PROVIDED BY THE CUSTOMER REVEALED A CRACK AT THE CHAMBER DOMES NEAR THE CHAMBER BASE. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT HAD CAUSED THE CRACKING ON THE CHAMBER DOME. EVERY MR290V CHAMBER 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 CHAMBERS WOULD HAVE MET THE REQUIRED SPECIFICATION AT THE TIME OF PRODUCTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION 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 ALARMS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK...

    Description of Event or Problem · 1

    A DISTRIBUTOR REPORTED ON BEHALF OF A HEALTHCARE FACILITY IN (B)(6) VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT FOUR MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE LEAKING WATER NEAR THE CHAMBER BASE DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538334 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1