BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 2529420 · Received April 11, 2012

    Report

    Report Number
    9611451-2012-00216
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 14, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THREE OF THE DEVICES INVOLVED IN THIS INCIDENT WERE RECEIVED FOR EVALUATION: MR850 HUMIDIFIER, A 900MR801 HEATER WIRE ADAPTOR (LOT 091109) AND A 900MR860 TEMPERATURE PROBE (LOT 100423). THE DEVICES WERE ALL VISUALLY INSPECTED AND PERFORMANCE TESTED TO CHECK FOR MALFUNCTIONS. QUESTIONS WERE ALSO SENT TO THE HOSPITAL IN AN ATTEMPT TO DISCOVER MORE DETAILS ABOUT THE SEQUENCE OF EVENTS. VISUAL INSPECTION OF THE COMPLAINT DEVICES: THE VISUAL EXAMINATION REVEALED THAT THE MAINS PLUG OF THE MR850 WAS BROKEN AND HELD TOGETHER WITH TAPE AND THE NEUTRAL PIN WAS BROKEN. THE HEATER WIRE ADAPTOR AND TEMPERATURE PROBE WERE BOTH UNDAMAGED. TEST RESULTS: BOTH THE HEATER WIRE ADAPTOR AND THE TEMPERATURE FLOW PROBE FUNCTIONED NORMALLY WHEN TESTED. MR850 HEATER BASE: THE LAST FAULT STATE CHECK REVEALED THAT AN ERROR CODE WAS RECORDED WHICH OCCURS WHEN THE HEATER PLATE ELEMENT IS NOT TURNING OFF. THE LAST ALARM STATE CHECK SHOWED THE TEMPERATURE INDICATOR LED WAS ON. THIS ALARM WILL OCCUR IF THE DISPLAYED TEMPERATURE IS TOO HIGH, OR IF THE DELIVERED TEMPERATURE HAS BEEN LOW FOR A PERIOD OF TIME. THE MR850 WAS PERFORMANCE TESTED USING A KNOWN WORKING CIRCUIT, PROBE, ADAPTOR AND ACCESSORIES. THE LAST FAULT /ALARM COULD NOT BE REPLICATED. THE MR850 PASSED ALL FUNCTIONAL TESTS AND NO FAULT WAS FOUND WITH THE DEVICE. PERFORMANCE TESTING OF THE COMPLAINT DEVICES: THE COMPLAINT MR850, HEATER WIRE ADAPTOR AND TEMPERATURE PROBE WERE SET UP FOR A PERFORMANCE TEST IN CONJUNCTION WITH A WORKING MR290 HUMIDIFICATION CHAMBER AND A HEATED BREATHING CIRCUIT. A FLOW OF 5 LPM WAS SUPPLIED AND THIS SETUP WAS TESTED FOR TWO DAYS WITHOUT ANY FAULT OR ALARM. THE DISPLAYED CHAMBER TEMPERATURE WAS 37.1 DEGREES C AND THE AIRWAY TEMPERATURE WAS 39.8 DEGREES C. IT MUST BE NOTED THAT WHEN FLOW WAS DISCONTINUED, THE DISPLAYED TEMPERATURE GRADUALLY DECREASED AND THE VISUAL TEMPERATURE INDICATOR WAS ACTIVATED BY THE MR850. CONCLUSION: NO FAULTS COULD BE FOUND WITH ANY OF THE DEVICES DURING TESTING. THE MR850 HAS BEEN DESIGNED SO THAT IN THE EVENT OF A FAILURE THE UNIT WILL SHUT DOWN IN A SAFE STATE AND WARN THE USER THAT A FAULT HAS OCCURRED. IT DOES THIS BY MONITORING THE CORRECT OPERATION OF ITS CRITICAL CIRCUITS. IF A FAULT IS DETECTED IT WILL TRY TO REPORT THIS BY GIVING AN ERROR CODE AND ALARMING VISUALLY AND AUDIBLY. FAILURE OF THE HEATER PLATE COMPONENT ON THE MR850 DOES NOT POSE ANY RISK TO A PATIENT AS IT RENDERS THE HEATER BASE INOPERABLE, NOR DOES IT AFFECT ANY OF THE MANY SAFETY SYSTEMS BUILT INTO THE MR850 HUMIDIFIER. THE INTERACTION BETWEEN, AND CONDITION OF, THE VARIOUS COMPONENTS, NAMELY THE HUMIDIFIER, THE SENSING PROBES, THE CHAMBER, THE BREATHING CIRCUIT AND THE PATIENT INTERFACE IS CRITICAL TO ENSURING SAFE AND EFFICACIOUS DELIVERY OF THERAPY. THE CONDITION OF THE RETURNED COMPLAINT MR850 INDICATED THAT IT MAY NOT BEEN PROPERLY MAINTAINED IN ACCORDANCE WITH THE MR850 PRODUCT TECHNICAL MANUAL. OUR MR850 PRODUCT TECHNICAL MANUAL CONTAINS A MAINTENANCE SCHEDULE WHICH INSTRUCTS THE USER TO CONDUCT ANNUAL VISUAL CHECKING AND PERFORMANCE TESTING OF THE MR850 HEATER BASE. THE USER IS LIKEWISE INSTRUCTED TO CONDUCT SIX-MONTHLY VISUAL CHECKS AND TEMPERATURE AND FLOW ACCURACY CHECKS OF THE TEMPERATURE PROBE AND TO REPLACE THE PROBE IF ANY DAMAGE OR MALFUNCTION IS NOTED. THE TECHNICAL MANUAL ALSO INSTRUCTS THE USER TO PERFORM AN ANNUAL CHECK OF THE HEATER WIRE ADAPTOR AND TO REPLACE THE ADAPTOR IF THERE IS ANY SIGN OF DAMAGE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THIS COMPLAINT ARE CURRENTLY EN ROUTE TO (B)(4). WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR850 RESPIRATORY HUMIDIFIER WHICH WAS BEING USED WITH BUBBLE CPAP WAS SHOWING A TEMPERATURE OF 60 DEGREES C. NO PATIENT CONSEQUENCE WAS REPORTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT AN MR850 RESPIRATORY HUMIDIFIER WHICH WAS BEING USED WITH BUBBLE CPAP WAS SHOWING A TEMPERATURE OF 60 DEGREES C. NO PATIENT CONSEQUENCE WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR850 070809

    Patients

    Seq Age Sex Outcome Treatment
    1 FISHER & PAYKEL TEMPERATURE FLOW PROBE| FISHER & PAYKEL HEATER WIRE ADAPTOR| FISHER & PAYKEL BUBBLE CPAP DELIVERY SYSTEM| FISHER & PAYKEL HEATER WIRE ADAPTOR| FISHER & PAYKEL MR290 HUMIDIFICATION CHAMBER| FISHER & PAYKEL TEMPERATURE FLOW PROBE| FISHER & PAYKEL MR290 HUMIDIFICATION CHAMBER| FISHER & PAYKEL BUBBLE CPAP DELIVERY SYSTEM