BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 3479999 · Received November 20, 2013

    Report

    Report Number
    9611451-2013-00930
    Event Type
    Malfunction
    Date Received
    November 20, 2013
    Date of Event
    October 24, 2013
    Report Date
    October 24, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE TWO COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS WERE NOT RETURNED TO FISHER & PAYKEL HEALTHCARE IN (B)(4) FOR EVALUATION. THE DEVICES WERE LOST IN TRANSIT BETWEEN THE CUSTOMER AND OUR GERMAN REGIONAL OFFICE. OUR EVALUATION IS BASED UPON INFORMATION FROM THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. THE HOSPITAL REPORTED THAT THE CHAMBERS HAD BEEN IN USE FOR TWO DAYS WHEN THE LEAK WAS DETECTED, AND THAT NO DISINFECTION OR CLEANING SOLUTION HAD COME INTO CONTACT WITH THE CHAMBER. THE HOSPITAL WAS UNABLE TO PROVIDE THE VENTILATOR SETTINGS OR THE TYPE OF THERAPY BEING USED AT THE TIME OF THE INCIDENT. A LOT CHECK REVEALED ONE OTHER COMPLAINT OF THIS NATURE FOR LOT 130307. IN THE ABSENCE OF THE DEVICES WE WERE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM REPORTED BY THE CUSTOMER. EVERY MR290 CHAMBER IS PRESSURE TESTED TO (B)(4) 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. THE CUSTOMER HAS REPORTED THAT THE CRACK APPEARED AFTER 4 TO 5 HOURS OF USE, INDICATING THE FAULT OCCURRED AFTER THE PRODUCTS WERE RELEASED FOR DISTRIBUTION. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: "SET APPROPRIATE VENTILATOR ALARMS." "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." "MAXIMUM OPERATING PRESSURE: 8 KPA." "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT TWO MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBERS LEAKED AFTER TWO DAYS OF USE. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    603403 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 130307

    Patients

    Seq Age Sex Outcome Treatment
    1 LEONIE PLUS| FISHER & PAYKEL HEALTHCARE RT265 BREATHING CIRCUIT