BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 2517496 · Received April 5, 2012

    Report

    Report Number
    9611451-2012-00202
    Event Type
    Injury
    Date Received
    April 5, 2012
    Date of Event
    March 6, 2012
    Report Date
    March 8, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALL THE DEVICES INVOLVED IN THIS INCIDENT WERE RECEIVED FOR EVALUATION: MR850 HUMIDIFIER, 3 MR290 CHAMBERS (ALL FROM LOT 101201), A SINGLE HEATED CIRCUIT (LOT UNKNOWN), A 900MR806 HEATER WIRE ADAPTOR (LOT 100914), A 900MR868 TEMPERATURE PROBE (LOT 100701) AND TWO PRESSURE MANIFOLDS. 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 AND THE STATUS OF THE BABY. THE HOSPITAL CONFIRMED THAT THE BABY WAS "ALRIGHT". WITH REGARD TO THE CARE AND MONITORING OF THE BABY, THE HOSPITAL REPORTED THAT THE BABY WAS LEFT UNATTENDED AT TIMES AND WAS ONLY CHECKED ONCE EVERY 30 MINUTES OR EVERY HOUR. VISUAL INSPECTION OF THE COMPLAINT DEVICES: THE VISUAL EXAMINATION REVEALED THAT THE MR850 HAD A BROKEN MAINS PLUG BUT WAS OTHERWISE UNDAMAGED. IN ONE OF THE PRESSURE MANIFOLDS THE SHROUD LOCKING CLIPS WERE BROKEN AND THE SHROUD WAS NOT PROPERLY FITTED. THE OTHER PRESSURE MANIFOLD WAS MISSING A PORT PLUG. THE HEATER WIRE ADAPTOR WAS UNDAMAGED. THE TEMPERATURE PROBE WAS DAMAGED, WITH BOTH FLOW THERMISTOR TIP AND CHAMBER THERMISTOR BROKEN. ALL THREE WATER CHAMBERS WERE DEFORMED AND THE DOMES WERE NO LONGER TRANSPARENT. TWO OF THE CHAMBERS HAD DENTED BASES. TEST RESULTS: HEATER WIRE ADAPTOR: FUNCTIONED NORMALLY WHEN TESTED. TEMPERATURE FLOW PROBE: AN AUDIBLE AND VISUAL TEMPERATURE PROBE ALARM WAS ACTIVATED WHEN THE 900MR868 WAS CONNECTED TO A MR850, INDICATING THAT THE PROBE WAS FAULTY. PRESSURE MANIFOLDS: DESPITE BOTH BEING PHYSICALLY DAMAGED, THE PRESSURE TEST SHOWED THAT THESE DEVICES WERE WITHIN SPECIFICATION AND FUNCTIONING NORMALLY. MR850 HEATER BASE: THE MR850 WAS PERFORMANCE TESTED USING A KNOWN WORKING CIRCUIT, PROBE, ADAPTOR AND ACCESSORIES. AFTER EIGHT MINUTES OF OPERATION THE MR850 DISPLAYED AN ERROR AND GAVE AN AUDIBLE ALARM. INVESTIGATION REVEALED THAT THE HEATER BASE HAD ALARMED DUE TO A FAULT IN THE HEATER PLATE TRIAC CIRCUITRY. PERFORMANCE TESTING OF THE COMPLAINT DEVICES: TEST 1: THE COMPLAINT MR850, HEATER WIRE ADAPTOR AND TEMPERATURE PROBE WERE SET UP FOR A PERFORMANCE TEST USING: MR290V CHAMBER MANUALLY FILLED WITH WATER UP TO THE MAXIMUM WATER LEVEL LINE. FLOW SOURCE THAT PROVIDED A FLOW OF 6L/MIN (AS PER FLOW RATE USED BY THE HOSPITAL) -SINGLE HEATED CIRCUIT. MULTIMETER WITH TEMPERATURE SENSOR.. TEST 1 RESULTS: AS THE MR850 WAS SWITCHED ON THE AUDIO ALARM SOUNDED AND THE VISUAL ALARM FOR FAULTY TEMPERATURE PROBE DISPLAYED. DESPITE THE ALARM THE MR850 STARTED HEATING FOR ABOUT FIVE MINUTES BEFORE SHUTTING DOWN THE HEATER PLATE. AFTER A COOLING PERIOD OF ABOUT 5 MINUTES THE MR850 STARTED HEATING AGAIN FOR ABOUT FIVE MINUTES. THIS CYCLING OF HEATING UP AND COOLING DOWN CONTINUED UNTIL THE MR850 WAS SWITCHED OFF AFTER ONE HOUR. DURING THIS ONE HOUR PERIOD, THE WATER IN THE CHAMBER WAS HEATED UP TO TEMPERATURES BETWEEN 86.2 C - 88.6 C AND COOLED DOWN TO TEMPERATURES BETWEEN 69.3 C - 70.3 C. THE CHAMBER DID NOT SOFTEN OR DEFORM AT ANY TIME DURING THIS TEST AND WE WERE THEREFORE UNABLE TO REPLICATE THE ISSUE EXPERIENCED BY THE CUSTOMER. TEST 2: THE RETURNED MR850AEU, HEATER WIRE ADAPTOR AND TEMPERATURE PROBE WERE SET UP FOR A PERFORMANCE TEST USING: MR290V CHAMBER MANUALLY FILLED WITH WATER UP TO THE MAXIMUM WATER LEVEL LINE. NO FLOW WAS APPLIED. SINGLE HEATED CIRCUIT. MULTIMETER WITH TEMPERATURE SENSOR. TEST 2 RESULTS: THE HEATER BASE STARTED HEATING AND AFTER ABOUT 10 MINUTES THE WATER IN THE CHAMBER STARTED TO BOIL. AFTER ABOUT 5 MINUTES CONTINUOUS BOILING WATER, THE CHAMBER STARTED TO SOFTEN AND TO DEFORM. AFTER HEATING CONTINUOUSLY HEATING FOR 20 MINUTES AND BOILING WATER FOR 10 MINUTES, THE HEATER BASE WAS SWITCHED OFF. A FLOW SOURCE WITH 6L/MIN WAS CONNECTED AND THE HEATER BASE WAS SWITCHED ON AGAIN. THE HEATER BASE STARTED HEATING UP AND COOLING DOWN AGAIN AS IT DID IN TEST 1. CONCLUSION: 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. OUR TESTING CONFIRMED THAT THE ONLY WAY THE CHAMBERS COULD HAVE DEFORMED WAS DUE TO A COMBINATION OF A FAULTY HEATER BASE, A FAULTY TEMPERATURE PROBE AND THE ABSENCE OF GAS FLOW. THE HOSPITAL HAS CONFIRMED THAT THE HEATER BASE ALARMED BUT THAT THEY DID NOT PAY ANY ATTENTION TO THIS. TESTING SHOWED THAT IT WOULD HAVE TAKEN ABOUT 20 MINUTES FOR THE CHAMBER TO HEAT UP AND SOFTEN, DURING WHICH TIME, THE HEATER BASE WOULD HAVE BEEN ALARMING VISUALLY AND AUDIBLY TO INDICATE A PROBLEM. 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 DEVICES INDICATED THAT THEY HAD 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.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A BABY WAS BEING TREATED WITH BUBBLE CPAP WHEN THE MR850 ALARMED. THE CHAMBER MR290 WAS OBSERVED TO BE "MELTING" AND WAS REPLACED ON THREE OCCASIONS. THE BABY WAS DESATURATED (40-50% OXYGEN SATURATION), BUT HAD EVENTUALLY STABILISED AND IS NOW "FINE". THE HOSPITAL CONFIRMED THAT THERE WAS NO INDICATION THAT THE BABY SUSTAINED ANY HEAT-RELATED INJURY AS A RESULT OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LTD MR850 100901

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R FISHER & PAYKEL MR290 HUMIDIFICATION CHAMBER| FISHER & PAYKEL 900MR868 TEMPERATURE FLOW PROBE| FISHER & PAYKEL BUBBLE CPAP DELIVERY SYSTEM| FISHER & PAYKEL 900MR806 HEATER WIRE ADAPTOR