BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUBBLE CPAP SYSTEM

    MDR report key: 2595131 · Received May 31, 2012

    Report

    Report Number
    9611451-2012-00338
    Event Type
    Malfunction
    Date Received
    May 31, 2012
    Date of Event
    September 15, 2011
    Report Date
    May 4, 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 BC160-10 BUBBLE CPAP SYSTEM IS DESIGNED FOR USE WITH SPONTANEOUSLY BREATHING INFANTS WHO REQUIRE CPAP THERAPY. THE HOSPITAL DID NOT CONFIRM WHETHER THE BREATHING CIRCUIT IN THE SET-UP HAD BEEN REUSED, BUT THEY HAVE STATED THAT THEY GENERALLY DISASSEMBLE THE SINGLE USE BUBBLE CPAP BREATHING CIRCUITS AND CLEAN THEM WITH 'SPIRITS' BEFORE BEING USED ON ANOTHER PATIENT. THE FOLLOWING COMPLAINT DEVICES AND OTHER COMPONENTS IN THE SET-UP WERE RETURNED TO FPH FOR INVESTIGATION: 1X MR850 HUMIDIFIER (B)(4), 1X MR290 CHAMBER, LOT 090109, 1X BC110 PRESSURE MANIFOLD, 1X 900MR801 HEATER WIRE ADAPTOR, LOT 090204, 1X 900MR860 TEMPERATURE FLOW PROBE, LOT 090828. 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 PROBE WAS PERFORMANCE TESTED. RESULTS: ALL THE DEVICES APPEARED TO HAVE SUSTAINED FIRE DAMAGE. - MR850 RESPIRATORY HUMIDIFIER: THE CHAMBER GUARD AND TOP RIGHT SECTION OF THE ENCLOSURE SHOWED SIGNS OF HEAT DAMAGE. THERE WAS NO POWER PLUG ATTACHED TO THE POWER CORD. THE LAST ALARM STATE SHOWED THAT THERE HAD BEEN A HEATER WIRE CONNECTOR ALARM. THIS INDICATOR LIGHTS UP IF THE HEATER WIRE IN THE BREATHING CIRCUIT HAS NOT BEEN CONNECTED CORRECTLY, OR IF THE HEATER WIRE OR HEATER WIRE ADAPTOR IS FAULTY. 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: THE CHAMBER WAS EXTENSIVELY FIRE DAMAGED: THE SECTION OF THE CHAMBER DOME WHERE THE INSPIRATORY LIMB IS CONNECTED HAD MELTED INTO THE CHAMBER BASE. - BC110 PRESSURE MANIFOLD: THE MANIFOLD WAS FIRE DAMAGED ALONG ITS ENTIRE LENGTH. - 900MR801 HEATER WIRE ADAPTOR: THE HEATER WIRE ADAPTOR IS DESIGNED TO CONNECT A HEATED BREATHING CIRCUIT TO THE HUMIDIFIER. VISUAL INSPECTION REVEALED THAT THERE WAS NO DAMAGE. THERE WAS NO AUDIBLE AND VISUAL TEMPERATURE PROBE ALARM ACTIVATED BY THE MR850 WHEN THE 900MR801 WAS CONNECTED INTO THE MR850. THE DEVICE WAS FOUND TO BE WITHIN SPECIFICATION. - 900MR860 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 BOTH THE CHAMBER AND THE FLOW THERMISTORS WERE MELTED AND CHARRED. THE PLUG WAS MISSING AND APPEARED TO HAVE BEEN CUT OFF. 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 HAD CAUSED THE HEATER WIRE INSULATION TO MELT AND ALLOWED THE BARE WIRES TO TOUCH EACH OTHER, RESULTING IN A SHORT CIRCUIT. THIS IS EVIDENT IN THE WAY THE CHAMBER DOME HAD MELTED; IT COULD BE SEEN THAT MOST OF THE DAMAGE WAS DONE AT THE CHAMBER PORT WHERE THE INSPIRATORY LIMB IS CONNECTED. 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 TO A FISHER & PAYKEL HEALTHCARE (FPH) REPRESENTATIVE DURING A SITE VISIT ON (B)(6) 2012 THAT A BC161-10 BUBBLE CPAP SYSTEM HAD CAUGHT FIRE ON (B)(6) 2011. 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 MR290 AUTOFEED HUMIDIFICATION CHAMBER| FPH MR850 HUMIDIFIER| FPH 900MR801 HEATER WIRE ADAPTOR