BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 10342288 · Received July 29, 2020

    Report

    Report Number
    9611451-2020-00663
    Event Type
    Malfunction
    Date Received
    July 29, 2020
    Date of Event
    June 14, 2020
    Report Date
    June 19, 2020
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PS344760 DEVICE 1: LOT 191114, DOM (B)(6)2019 , DEVICE 2: LOT 191005, DOM (B)(6)2019 , DEVICE 3: LOT 191005, DOM (B)(6)2019 , DEVICE 4: LOT 200109, DOM (B)(6)2020 , DEVICE 5: LOT 200109, DOM (B)(6)2020 , DEVICE 6: LOT 200228, DOM (B)(6)2020 , DEVICE 7: LOT 191005, DOM (B)(6)2019 , DEVICE 8: LOT 190802, DOM (B)(6)2019. METHOD: THE EIGHT COMPLAINT MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN NEW ZEALAND FOR EVALUATION WHERE THEY WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF SEVEN COMPLAINT MR290 CHAMBERS (DEVICE 1, 2, 3, 5, 6, 7, 8) REVEALED A HORIZONTAL CRACK LINE ON THE LOWER PART OF DOME. VISUAL INSPECTION OF ONE COMPLAINT CHAMBER (DEVICE 4) REVEALED NO CRACKS. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE CRACK ON SEVEN OF THE COMPLAINT CHAMBER DOMES. THE CRACK IS MOST LIKELY DUE TO MECHANICAL STRESS HOWEVER THE STRESS SOURCE IS UNKNOWN. THERE WAS NO FAULT FOUND WITH ONE CHAMBER (DEVICE 4). 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 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 FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN SWITZERLAND REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT EIGHT MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND LEAKING WATER NEAR THE BASE OF THE HEATER PLATE. THERE WAS NO PATIENT CONSEQUENCE.

    Additional Manufacturer Narrative · 1

    PS344760. THE COMPLAINT MR290 VENTED AUTOFEED HUMIDIFICATION 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 (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT EIGHT MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE FOUND LEAKING WATER NEAR THE BASE OF THE HEATER PLATE. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806130 VENTED AUTOFEED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT MR290VX SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 F&P MR850 RESPIRATORY HUMIDIFIER| F&P MR850 RESPIRATORY HUMIDIFIER