BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 8402609 · Received March 8, 2019

    Report

    Report Number
    9611451-2019-00195
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Date of Event
    January 22, 2019
    Report Date
    February 7, 2019
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PS301803 CORRECTION: SECTION D4- LOT NUMBER AMENDED TO 180924, SECTION H4 DEVICE MANUFACTURE DATE AMMENDED TO (B)(6)2018. CORRECT DEVICE LOT NUMBER RECEIVED DURING INVESTIGATION. METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND FOR INVESTIGATION. THE CHAMBER WAS VISUALLY INSPECTED FOR THE REPORTED DAMAGE AND SUBSEQUENTLY FILLED WITH WATER. RESULTS: VISUAL INSPECTION OF THE COMPLAINT MR290V CHAMBER IDENTIFIED A CRACK ON THE CHAMBER DOME. WHEN THE CHAMBER WAS FILLED WITH WATER, A LEAK WAS OBSERVED. CONCLUSION: WE WERE UNABLE TO DETERMINE WHAT HAD CAUSED THE CRACKING ON THE CHAMBER DOME. HOWEVER, BASED ON CRACK PATTERN, IT IS MOST LIKELY TO BE DUE TO PHYSICAL DAMAGE. EVERY MR290 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 CHAMBER 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 FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS LEAKING WATER FROM THE BASE OF THE CHAMBER DOME. THERE WAS NO PATIENT CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER HAS BEEN RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) AND IS CURRENTLY IN THE PROCESS OF EVALUATION. WE WILL PROVIDE A FOLLOW UP UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN THE (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS LEAKING WATER FROM THE BASE OF THE CHAMBER DOME. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195814 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 180924

    Patients

    Seq Age Sex Outcome Treatment
    1 F&P OPTIFLOW JUNIOR INTERFACE| F&P OPTIFLOW JUNIOR INTERFACE| F&P RT330 INFANT CIRCUIT| F&P RT330 INFANT CIRCUIT