BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 2529416 · Received April 11, 2012

    Report

    Report Number
    9611451-2012-00217
    Event Type
    Malfunction
    Date Received
    April 11, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 13, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL THE DEVICES INVOLVED IN THIS INCIDENT WERE RECEIVED FOR EVALUATION: MR850 HUMIDIFIER, AN MR290 CHAMBER (LOT 110512), A BC060 INSPIRATORY LIMB, A 900MR801 HEATER WIRE ADAPTOR (LOT 090721), A 900MR869 TEMPERATURE PROBE (LOT 100928), A BC100 CPAP GENERATOR AND A BC110 PRESSURE MANIFOLD. 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 THERE WAS NO PHYSICAL DAMAGE EVIDENT IN ANY OF THE DEVICES. TEST RESULTS: THE BC060 INSPIRATORY LIMB WAS RESISTANCE TESTED AND FOUND TO BE WITHIN SPECIFICATION. BOTH THE HEATER WIRE ADAPTOR AND THE TEMPERATURE FLOW PROBE FUNCTIONED NORMALLY WHEN TESTED. THE CUSTOMER HAD REPORTED THAT A 'HEATER WIRE DISCONNECT' ALARM HAD DISPLAYED PRIOR TO THEM SWAPPING OUT THE HEATER WIRE ADAPTOR. IT IS LIKELY THAT THE ORIGINAL HEATER WIRE ADAPTOR WAS OPEN CIRCUIT, WHICH WOULD EXPLAIN WHY THIS ALARM DISPLAYED. THE PRESSURE MANIFOLD WAS PRESSURE TESTED AND FOUND TO BE WITHIN SPECIFICATION. THE MR850 HEATER BASE WAS PERFORMANCE TESTED USING A KNOWN WORKING CIRCUIT, PROBE, ADAPTOR AND ACCESSORIES. THE MR850 FUNCTIONED NORMALLY DURING TESTING. 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 (THE COMPLAINT BREATHING CIRCUIT WAS NOT USED DUE TO CONTAMINATION CONCERNS). A FLOW OF 5LPM WAS SUPPLIED AND THIS SETUP WAS TESTED FOR TWO DAYS WITHOUT ANY FAULT OR ALARM. THE DISPLAYED CHAMBER TEMPERATURE WAS 36.7 DEGREES C AND THE AIRWAY TEMPERATURE WAS 39.4 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 FAULT WAS FOUND WITH ANY OF THE DEVICES AND ALL FUNCTIONED NORMALLY DURING TESTING. WE WERE THEREFORE UNABLE TO DETERMINE WHAT HAD CAUSED THE PROBLEM AS DESCRIBED BY THE CUSTOMER. 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. 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 WAS BEING USED WITH BUBBLE CPAP WHEN THE MR850 DISPLAYED A HEATER WIRE DISCONNECT ALARM. THE HOSPITAL FURTHER REPORTED THAT WHEN THE HEATER WIRE ADAPTOR WAS EXCHANGED THE CHAMBER TEMPERATURE WAS SHOWING AS 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 WAS BEING USED WITH BUBBLE CPAP WHEN THE MR850 DISPLAYED A HEATER WIRE DISCONNECT ALARM. THE HOSPITAL FURTHER REPORTED THAT WHEN THE HEATER WIRE ADAPTOR WAS EXCHANGED THE CHAMBER TEMPERATURE WAS SHOWING AS 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 110516

    Patients

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