BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED HUMIDIFICATION CHAMBER

    MDR report key: 5363261 · Received January 13, 2016

    Report

    Report Number
    9611451-2016-00014
    Event Type
    Malfunction
    Date Received
    January 13, 2016
    Date of Event
    December 10, 2015
    Report Date
    December 14, 2015
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (FPH) FOR INVESTIGATION AS IT WAS DISCARDED AT THE HOSPITAL FACILITY BEFORE THE INCIDENT WAS REPORTED. HOSPITAL STAFF PROVIDED ADDITIONAL INFORMATION REGARDING THE REPORTED COMPLAINT. OUR ANALYSIS IS ACCORDINGLY BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL STAFF AND OUR KNOWLEDGE OF THE PRODUCT. HOSPITAL STAFF REPORTED THAT THE COMPLAINT MR290 CHAMBER HAD BEEN IN USE FOR TWO DAYS AND DID NOT RUN DRY DURING THIS TIME. STAFF ALSO REPORTED THAT IT WAS POSSIBLE FOR THE CHAMBER TO HAVE COME INTO CONTACT WITH A HAND DISINFECTION SOLUTION (DAX). WITHOUT THE COMPLAINT DEVICE, WE ARE UNABLE TO DETERMINE WHAT MAY HAVE CAUSED THE PROBLEM REPORTED BY THE HOSPITAL. BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL, IT IS POSSIBLE THAT THE CHAMBER CAME INTO CONTACT WITH THE DAX SOLUTION, IN WHICH THE ETHANOL CONTENT CONTRIBUTED TOWARDS STRESS CRACKING OF THE CHAMBER DOME. IF THE COMPLAINT DEVICE WAS RETURNED, IT WOULD HAVE BEEN VISUALLY INSPECTED FOR CRACKS AND RESIDUES. ALL MR290 CHAMBERS ARE VISUALLY INSPECTED AND PRESSURE TESTED BEFORE THEY LEAVE THE PRODUCTION LINE. CHAMBERS THAT FAIL ANY OF THESE TESTS ARE DISCARDED. THIS SUGGESTS THAT THE PROBLEM OCCURRED AFTER THE SUBJECT MR290 CHAMBER WAS RELEASED FOR DISTRIBUTION. 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." "USE OF THE MR290 ABOVE THE MAXIMUM OPERATING PRESSURE MAY LEAD TO CRACKING, WATER LEAKAGE AND, OR RARE OCCASIONS, COULD LEAD TO A LOSS OF VENTILATION PRESSURE." "ENSURE THERE IS A WATER SUPPLY CONNECTED TO THE CHAMBER AND THAT WATER IS PRESENT WITHIN THE CHAMBER." "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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA AN FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT ONE MR290 HUMIDIFICATION CHAMBER CRACKED DURING USE. NO PATIENT CONSEQUENCE WAS REPORTED. THE COMPLAINT MR290 CHAMBER WAS DISCARDED AT THE HOSPITAL FACILITY BEFORE THE INCIDENT WAS REPORTED TO FPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22062 VENTED HUMIDIFICATION CHAMBER AUTOFEED CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V 140817

    Patients

    Seq Age Sex Outcome Treatment
    1