BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE CPAP SYSTEM

    MDR report key: 2592870 · Received May 30, 2012

    Report

    Report Number
    9611451-2012-00337
    Event Type
    Malfunction
    Date Received
    May 30, 2012
    Date of Event
    April 12, 2012
    Report Date
    May 3, 2012
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K100011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BC161-10 BUBBLE CPAP SYSTEM IS DESIGNED FOR USE WITH SPONTANEOUSLY BREATHING INFANTS WHO REQUIRE CPAP THERAPY. QUESTIONS WERE SENT TO THE HOSPITAL TO DISCOVER MORE DETAILS ABOUT THE SEQUENCE OF EVENTS. THE HOSPITAL CONFIRMED THAT THE CIRCUIT HAD BEEN REUSED. THEY STATED THAT THE CIRCUIT HAD BEEN DISASSEMBLED AND THEN CLEANED WITH 'SPIRITS' BEFORE BEING USED ON THIS PATIENT. THEY ALSO CONFIRMED THAT THE INFANT PATIENT WAS IN A PHOENIX OLW100 WARMER UNIT. THE FOLLOWING COMPLAINT DEVICES AND OTHER COMPONENTS IN THE SET-UP WERE SUBSEQUENTLY RETURNED TO FPH FOR INVESTIGATION: 1X MR850 HUMIDIFIER SN (B)(4). 1X MR290 CHAMBER LOT 090722; 1X BC110 PRESSURE MANIFOLD; 1X INSPIRATORY LIMB CHAMBER ELBOW; 1X 900MR869 TEMPERATURE FLOW PROBE LOT 110223. METHOD: THE DEVICES WERE ALL VISUALLY INSPECTED. IN ADDITION, THE MR850 WAS POWERED ON TO CHECK THE LAST ALARM STATE AND LAST FAULT STATE AND THE UNIT WAS PERFORMANCE TESTED. THE MANIFOLD WAS PRESSURE TESTED AND THE PROBE WAS PERFORMANCE TESTED. RESULTS: MR850 RESPIRATORY HUMIDIFIER: NO DAMAGE WAS OBSERVED ON THE UNIT, BUT THE POWER PLUG FITTED TO THE MR850 WAS HELD TOGETHER WITH TAPE. THE LAST ALARM STATE SHOWED THAT THERE HAD BEEN A 'WATER OUT' ALARM. THE LAST FAULT STATE WAS E00, INDICATING THAT THERE WAS NO FAULT WITH THE FUNCTIONING OF THE MR850. THE MR850 ALSO PASSED ALL FUNCTIONAL CHECKS AND WAS TEST RUN FOR FOUR HOURS WITH NO ERRORS. MR290 CHAMBER: NO DEFECT OR DAMAGE WAS OBSERVED. BC110 PRESSURE MANIFOLD: PRESSURE TESTING REVEALED THAT THE MANIFOLD WAS WITHIN SPECIFICATION. INSPIRATORY LIMB CHAMBER ELBOW: THE ELBOW WAS BURNT AT THE END THAT CONNECTS TO THE INSPIRATORY LIMB, ALTHOUGH THE LIMB ITSELF WAS NOT SUPPLIED. 900MR869 TEMPERATURE FLOW PROBE: THE TEMPERATURE FLOW PROBE CONSISTS OF SEPARATE CHAMBER AND PATIENT/AIRWAY THERMISTORS. IT IS INSERTED INTO THE BREATHING CIRCUIT SYSTEM TO MONITOR TEMPERATURE AND FLOW OF VENTILATORY GASES AT EACH END OF THE BREATHING CIRCUIT. THE PROBE RELAYS THIS INFORMATION BY WAY OF ELECTRICAL FEEDBACK TO THE HUMIDIFIER. INSPECTION REVEALED THAT THE CHAMBER THERMISTOR WAS MELTED AND CHARRED. WHEN THE COMPLAINT (B)(4) WAS CONNECTED TO A MR850 AN AUDIBLE AND VISUAL TEMPERATURE PROBE ALARM WAS ACTIVATED BY THE MR850 REVEALING THAT THE PROBE WAS OUT OF SPECIFICATION. CONCLUSION: FURTHER TO OUR INSPECTION OF THE COMPLAINT DEVICE AND COMPONENTS, IT IS MOST LIKELY THAT THE CAUSE OF THE FIRE WAS OVERHEATING OF THE HEATER WIRE DUE TO HEATER WIRE BUNCHING IN THE CHAMBER PORT END OF THE INSPIRATORY LIMB AS A RESULT OF CLEANING AND REUSE. EXCESSIVE HEAT DUE TO BUNCHING OF THE HEATER WIRE HAS CAUSED THE HEATER WIRE INSULATION TO MELT AND ALLOWED THE BARE WIRES TO TOUCH EACH OTHER, RESULTING IN A SHORT CIRCUIT. FPH'S USER INSTRUCTIONS THAT ACCOMPANY THE BC161 BUBBLE CPAP DELIVERY SYSTEM CONTAINS THE FOLLOWING STATEMENTS TO WARN THE USER AGAINST POTENTIAL LOCALISED OVERHEATING: CHECK THAT THE HEATER WIRE IS EVENLY DISTRIBUTED ALONG THE CIRCUIT IN EACH LIMB AND NOT BUNCHED OR KINKED. DO NOT STRETCH OR MILK THE TUBING. DO NOT SOAK, WASH, STERILIZE OR RE-USE THIS PRODUCT.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT A FISHER & PAYKEL HEALTHCARE (FPH) BC161-10 BUBBLE CPAP SYSTEM CAUGHT FIRE. THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BUBBLE CPAP SYSTEM BTT BTT FISHER & PAYKEL HEALTHCARE LTD BC161-10

    Patients

    Seq Age Sex Outcome Treatment
    1 FPH MR850 HUMIDIFIER| PHOENIX OLW100 INFANT WARMER| FPH 900MR869 TEMPERATURE/FLOW PROBE| FPH MR290 AUTOFEED HUMIDIFICATION CHAMBER