BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 9735424 · Received February 20, 2020

    Report

    Report Number
    9611451-2020-00176
    Event Type
    Malfunction
    Date Received
    February 20, 2020
    Report Date
    January 23, 2020
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). DEVICE 1: LOT NO. 190822. MANUFACTURING DATE: 22 AUG 2019. DEVICE 1: LOT NO. 190114. MANUFACTURING DATE: 14 JAN 2019. DEVICE 1: LOT NO. 190611. MANUFACTURING DATE: 11 JUN 2019. METHOD: THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE RETURNED TO FISHER & PAYKEL HEALTHCARE IN NEW ZEALAND WHERE THEY WERE VISUALLY INSPECTED. RESULTS: VISUAL INSPECTION OF THE RETURNED COMPLAINT MR290 CHAMBERS IDENTIFIED MULTIPLE CRACK LINES ON THE DOME AT VARIOUS PLACES FOR DEVICE 1. SMEARED INK WAS ALSO OBSERVED. FOR DEVICES 2 AND 3, HORIZONTAL CRACK NEAR THE LOWER PART OF THE CHAMBER DOME WERE OBSERVED. CONCLUSION: WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE REPORTED EVENT. FOR DEVICE 1, THE LIKELY CAUSE MAY BE DUE TO USE OF ALCOHOL CLEANING AGENTS. 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 HUMIFICATION 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 THE NETHERLANDS REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THREE MR290V VENTED HUMIDIFICATION CHAMBERS HAD A CRACKED DOME DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICES ARE CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (B)(4) FOR EVALUATION TO DETERMINE IF F&P'S PRODUCTS CAUSED OR CONTRIBUTED THE REPORTED EVENT. 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 MR290V VENTED HUMIDIFICATION CHAMBERS HAD A CRACKED DOME DURING USE. THERE WERE NO REPORTED PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199705 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT MR290V SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1