BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 2223778 · Received August 25, 2011

    Report

    Report Number
    9611451-2011-00518
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 27, 2011
    Report Date
    July 28, 2011
    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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR290V CHAMBER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE FOR EVALUATION AS IT HAD BEEN DISCARDED AT THE HEALTHCARE FACILITY. OUR ANALYSIS IS ACCORDINGLY BASED ON THE EVENT DESCRIPTION AND OUR KNOWLEDGE OF THE PRODUCT. WITHOUT A COMPLAINT DEVICE WE ARE UNABLE TO DETERMINE WHAT CAUSED THE PROBLEM OBSERVED BY THE HEALTHCARE FACILITY. THE MR290 IS A SINGLE USE AUTOFEED HUMIDIFICATION CHAMBER USED TO MAINTAIN CONSTANT HUMIDITY LEVEL FOR THE PATIENT. IT HAS A UNIQUE DUAL FLOAT MECHANISM THAT USES INDEPENDENT FLOATS TO CONTROL THE AMOUNT OF WATER WHICH FLOWS INTO THE CHAMBER AND TO SAFELY MAINTAIN A CONSTANT WATER LEVEL INSIDE THE CHAMBER FOR OPTIMAL HUMIDIFICATION. UNDER NORMAL CIRCUMSTANCES, THE BLUE "PRIMARY" FLOAT CONTROLS THE WATER LEVEL IN THE CHAMBER AND THE WHITE "SECONDARY" FLOAT ACTS AS A BACKUP TO PREVENT OVERFILLING IF THE PRIMARY FLOAT FAILS TO OPERATE. THE MR290 USER INSTRUCTIONS ILLUSTRATE THAT THE WATER SOURCE (BAG OR BOTTLE) MUST BE MOUNTED A MINIMUM OF 50 CENTIMETERS ABOVE THE CHAMBER TO ENSURE PROPER WATER FLOW. IT ALSO ADVISES THAT THE FILTER CAP MUST BE OPENED IF A WATER BAG OR BOTTLE IS USED. THE USER INSTRUCTIONS ALSO STATE "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT."

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT AN MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS NOT AUTO FILLING. THIS WAS NOTICED DURING USE ON A PATIENT. NO PATIENT CONSEQUENCE WAS REPORTED. ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE FACILITY CONFIRMED THAT THE COMPLAINT MR290V CHAMBER HAD BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTED AUTOFEED HUMIDIFICATION CHAMBER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR290V 110214

    Patients

    Seq Age Sex Outcome Treatment
    1 RT200 ADULT DUAL-HEATED BREATHING CIRCUIT