BEUDAMED
    FDA Adverse Event Other Summary report: N

    RESPIRATORY HUMIDIFIER

    MDR report key: 1455883 · Received August 25, 2009

    Report

    Report Number
    9611451-2009-00465
    Event Type
    Other
    Date Received
    August 25, 2009
    Report Date
    August 1, 2009
    Manufacturer
    FISHER & PAYKEL HEALTHCARE, LTD.
    Product Code
    BTT
    PMA / PMN Number
    K953392
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOWING NOTIFICATION OF THIS INCIDENT, FISHER & PAYKEL HEALTHCARE'S ('FPH') CLINICAL PRODUCTS MANAGER BASED IN FPH'S BRANCH OFFICE IN (B)(4) CONTACTED THE PATIENT'S PARENT TO OBTAIN FURTHER INFORMATION. FPH IS CURRENTLY SEEKING CLARIFICATION IN RESPECT OF THE PATIENT'S CURRENT STATUS, MEDICAL INTERVENTION REQUIRED (IF ANY) AS A RESULT OF THE INCIDENT AND OTHER PERTINENT DETAILS TO FURTHER ASSIST IN OUR ANALYSIS. FPH DID NOT MANUFACTURE THE BREATHING CIRCUIT USED IN THE EQUIPMENT SET-UP AT THE TIME OF THE INCIDENT. FPH HAS NOT RECEIVED ANY INFORMATION THAT SUGGESTS THE HC500 RESPIRATORY HUMIDIFIER ('THE HUMIDIFIER') HAS MALFUNCTIONED. THE HUMIDIFIER AND ASSOCIATED MEDICAL DEVICES AND COMPONENTS ARE NOT EXPECTED TO BE RETURNED TO FPH FOR INSPECTION. WE HAVE HOWEVER RECEIVED PHOTOGRAPHS OF THE BREATHING CIRCUIT. THESE PHOTOGRAPHS WILL BE USED IN OUR FINAL EVALUATION IN CONJUNCTION WITH ALL AVAILABLE INFORMATION PERTAINING TO THE INCIDENT. AS FAR AS FPH IS AWARE, THE HUMIDIFIER IS CURRENTLY STILL IN SERVICE WITH NO REPORT OF FURTHER INCIDENT. FPH'S OPERATING MANUAL THAT ACCOMPANIES THE HC500 HUMIDIFIER SPECIFIES THE WARING THAT "TO PREVENT THE POSSIBILITY OF ACCIDENTAL PATIENT BURNS, ENSURE THAT THE HEATED BREATHING CIRCUIT IS NOT IN CONTACT WITH THE PATIENT'S SKIN." WE WILL SUBMIT OUR FINDINGS AND/OR ADDITIONAL INFORMATION IN A FOLLOW-UP REPORT FOLLOWING RECEIPT OF THE DETAILS REQUESTED AND COMPLETION OF OUR ANALYSIS.

    Description of Event or Problem · 1

    THE PARENT OF A PEDIATRIC PATIENT REPORTED THE FOLLOWING INCIDENT VIA FISHER & PAYKEL HEALTHCARE'S ('FPH') CUSTOMER INQUIRY WEBSITE: IN A SET-UP INVOLVING THE HC500 RESPIRATORY HUMIDIFIER AND AIRLIFE 1006-H05 HEATED BREATHING CIRCUIT ('THE BREATHING CIRCUIT'), A PORTION OF THE BREATHING CIRCUIT ALLEGEDLY MELTED, CAUSING A SECOND DEGREE BURN OF APPROXIMATELY 2 INCHES LONG ON THE OUTER THIGH OF THE PATIENT AT THE UPPER LEFT SIDE. THE PATIENT'S PARENT REPORTED THAT THE CAREGIVER IN ATTENDANCE AT THE TIME OF THE INCIDENT TURNED ON THE GAS SUPPLY FROM THE COMPRESSOR THAT WAS USED IN CONJUNCTION WITH THE ABOVE DEVICES BUT DID NOT NOTICE THAT THE COMPRESSOR WAS NOT PLUGGED IN TO THE MAINS ELECTRICAL SUPPLY, RESULTING IN NO GAS FLOWING THROUGH THE BREATHING CIRCUIT. THE PATIENT'S PARENT FURTHER STATED THAT NO ALARMS WERE ACTIVATED AT THE TIME OF THE INCIDENT. FPH IS CURRENTLY IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION TO ASSIST IN OUR INVESTIGATION OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESPIRATORY HUMIDIFIER BTT FISHER & PAYKEL HEALTHCARE, LTD. HC500JHU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FISH & PAYKEL HEALTHCARE: (B)(4) HEATER WIRE| EASY AIR COMPRESSOR| AIRLIFE: 1006-H05 HEATED BREATHING CIRCUIT| ADAPTER| INVACARE: OXYGEN CONCENTRATOR