BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 3090870 · Received May 2, 2013

    Report

    Report Number
    9611451-2013-00328
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 10, 2013
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LIMITED
    Product Code
    BTT
    PMA / PMN Number
    K033710
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT MR850AFU RESPIRATORY HUMIDIFIER WILL BE RETURNED TO FPH SERVICE CENTRE IN (B)(4) FOR INSPECTION. WE ARE ALSO IN THE PROCESS OF OBTAINING FURTHER INFORMATION FROM THE HEALTHCARE FACILITY IN ORDER TO ASSIST US WITH THE ANALYSIS AND IDENTIFICATION OF A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT. WE WILL PROVIDE A FOLLOW-UP REPORT ONCE WE HAVE INSPECTED THE COMPLAINT DEVICE AND COMPLETED OUR ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). METHOD: THE COMPLAINT MR850AFU RESPIRATORY HUMIDIFIER, 900MR800 HEATER WIRE ADAPTOR, AND 900MR868 TEMPERATURE PROBE WERE RETURNED TO THE FPH SERVICE CENTRE IN (B)(4) FOR INSPECTION. THE DEVICES WERE VISUALLY INSPECTED AND PERFORMANCE TESTED AS PER MR850 PRODUCT TECHNICAL MANUAL TO CONFIRM THE REPORTED FAULT. OUR ANALYSIS IS ACCORDINGLY BASED ON THE INSPECTION RESULTS, AND ADDITIONAL INFORMATION PROVIDED BY THE HOSPITAL. RESULTS: THE RETURNED DEVICES WERE INSPECTED EXTERNALLY AND NO ISSUES WERE NOTED. THE SUBJECT MR850AFU HUMIDIFIER AND ITS ACCESSORIES PASSED THE PERFORMANCE CHECKS. THE HUMIDIFIER WAS ALSO TESTED FOR CORRECT ACTIVATION OF THE WATER OUT ALARM BY RUNNING IT FOR 30 MINUTES, ALLOWING THE HUMIDIFICATION CHAMBER TO RUN DRY. IT CONTINUED RUNNING UNTIL THE WATER INSIDE THE CHAMBER HAD EVAPORATED AND, AT THE END OF THIS PERIOD, THE WATER OUT ALARM CORRECTLY SOUNDED ON THE HUMIDIFIER. A LOT CHECK REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR LOT NUMBER 120301. CONCLUSION: NO FAULT WAS FOUND WITH THE SUBJECT MR850AFU HUMIDIFIER AND ITS ACCESSORIES AS THEY PASSED THE VISUAL INSPECTIONS AND PERFORMANCE CHECKS. THE DEVICES WERE RETURNED TO THE HOSPITAL AFTER THE INSPECTION. WE WERE UNABLE TO DETERMINE DEFINITIVELY THE ROOT CAUSE OF THE REPORTED RED MARKS ON THE PATIENT'S FACE. THE HOSPITAL STATED THAT THE RED MARKS WERE TEMPORARY IN NATURE AND DISAPPEARED WHEN THE PATIENT WAS REMOVED FROM THE DEVICE.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A PATIENT ALLEGEDLY SUSTAINED RED MARKS ON THE FACE (A SUPERFICIAL BURN) DURING NON-INVASIVE TREATMENT USING AN MR850AFU RESPIRATORY HUMIDIFIER AND AN OPTIFLOW SYSTEM. IT WAS FURTHER REPORTED THAT THE CHAMBER, WHICH WAS CONNECTED TO THE HUMIDIFIER, RAN OUT OF WATER BUT NO ALARM SOUNDED ON THE HUMIDIFIER. THE HEALTHCARE FACILITY SUBSEQUENTLY CLARIFIED THAT THE REDNESS WAS TEMPORARY AND THAT ¿EVERYTHING WAS QUICKLY BACK TO NORMAL¿ UPON CORRECTION OF THE REPORTED SITUATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED TO A FISHER & PAYKEL HEALTHCARE (FPH) FIELD REPRESENTATIVE THAT A PATIENT ALLEGEDLY SUSTAINED RED MARKS ON THEIR FACE (A SUPERFICIAL BURN) DURING NON-INVASIVE TREATMENT USING AN MR850AFU RESPIRATORY HUMIDIFIER AND AN OPTIFLOW SYSTEM. IT WAS FURTHER REPORTED THAT THE CHAMBER, WHICH WAS CONNECTED TO THE HUMIDIFIER, RAN OUT OF WATER BUT NO ALARM SOUNDED ON THE HUMIDIFIER. THE HEALTHCARE FACILITY SUBSEQUENTLY CLARIFIED THAT THE REDNESS WAS TEMPORARY AND THAT "EVERYTHING WAS QUICKLY BACK TO NORMAL" UPON CORRECTION OF THE REPORTED SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191887 RESPIRATORY HUMIDIFIER BTT BTT FISHER & PAYKEL HEALTHCARE LIMITED MR850AFU

    Patients

    Seq Age Sex Outcome Treatment
    1