BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADULT BREATHING CIRCUIT

    MDR report key: 1221525 · Received November 5, 2008

    Report

    Report Number
    9611451-2008-00649
    Event Type
    Malfunction
    Date Received
    November 5, 2008
    Report Date
    October 6, 2008
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD.
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). METHOD: THE HOSPITAL DID NOT RELEASE THE DEVICES TO FISHER & PAYKEL HEALTHCARE (FPH) FOR INVESTIGATION. FPH REPRESENTATIVES WERE ABLE TO INSPECT THE DEVICES AT THE HOSPITAL AND TAKE PHOTOGRAPHS, BUT WERE NOT PERMITTED TO CUT OPEN THE BREATHING CIRCUIT TO PROPERLY INSPECT THE INTERNAL HEATERWIRE. A LIMITED INVESTIGATION WAS CARRIED OUT BASED ON THE EVENT INFORMATION AND THE PHOTOGRAPHS PROVIDED. RESULTS: THE RT210 BREATHING CIRCUIT USED IS DUAL HEATED, AND THEREFORE IS INTENDED FOR APPLICATIONS NOT REQUIRING A WATER TRAP. A WATER TRAP AND TUBING MADE BY ANOTHER MANUFACTURER WAS CONNECTED TO THE END OF THE EXPIRATORY TUBE AND TO THE VENTILATOR. THE END OF THE RT210 EXPIRATORY TUBE IS NORMALLY CONNECTED TO THE VENTILATOR. THIS ADDITION MADE THE BREATHING CIRCUIT SETUP SIGNIFICANTLY LONGER SO THAT IT HUNG LOW TO THE GROUND. THE PHOTOGRAPHS SHOW THE BREATHING CIRCUIT HAD MELTED COMPLETELY THROUGH AT ONE POINT. THE MELT OCCURRED AT THE END OF THE EXPIRATORY TUBE AWAY FROM THE PATIENT, ADJACENT TO WHERE THE UNEXPECTED WATER TRAP WAS CONNECTED. A LOT CHECK REVEALED NO OTHER SIMILAR COMPLAINTS FOR THIS LOT NUMBER. CONCLUSION: WE CANNOT YET CONCLUDE HOW THE BREATHING CIRCUIT MELT OCCURRED. WE ARE CONTINUING TO ATTEMPT TO OBTAIN MORE INFORMATION RELEVANT TO THE EVENT AND TO OBTAIN THE COMPLAINT DEVICE FOR A FULL INSPECTION. WE WILL PROVIDE A FOLLOW UP REPORT IF ANY NEW INFORMATION IS FORTHCOMING.

    Description of Event or Problem · 1

    A HOSPITAL IN (B) (6) REPORTED VIA OUR DISTRIBUTOR THAT A GLOW AND SMOKE WAS OBSERVED INSIDE AN RT210 DUAL HEATED ADULT BREATHING CIRCUIT. A NURSE AND THE RESPIRATORY THERAPIST DISCONNECTED THE SETUP FROM THE PATIENT. AS THERE WAS SOME SMOKE IN THE ROOM, THE FIRE ALARM WAS ACTIVATED AND THE FIRE DEPARTMENT CAME TO THE HOSPITAL. IT WAS INITIALLY REPORTED TO FISHER & PAYKEL HEALTHCARE THAT THE PATIENT SUSTAINED NO PHYSICAL INJURIES. FOLLOWING THIS EVENT, THE PATIENT UNDERWENT A BRONCHOSCOPY AS A PRECAUTION TO CHECK THE CONDITION OF THE PATIENT'S LUNGS. A STAFF MEMBER AT THE HOSPITAL THEN CONFIRMED TO A FISHER & PAYKEL HEALTHCARE REPRESENTATIVE THAT "THE PATENT RECEIVED NO ADVERSE OUTCOME FROM THIS EVENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADULT BREATHING CIRCUIT BTT FISHER & PAYKEL HEALTHCARE LTD. RT210 051011

    Patients

    Seq Age Sex Outcome Treatment
    1 PB7200 VENTILATOR| MR850 RESPIRATORY HUMIDIFIER| UNSPECIFIED WATER TRAP AND TUBING