BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLOW OXYGEN KIT

    MDR report key: 7745888 · Received August 3, 2018

    Report

    Report Number
    9611451-2018-00656
    Event Type
    Injury
    Date Received
    August 3, 2018
    Date of Event
    July 5, 2018
    Report Date
    July 5, 2018
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AA400 OXYGEN KIT IS NOT SOLD IN THE USA BUT IT IS SIMILAR TO A PRODUCT SOLD IN THE USA. THE 510(K) FOR THAT PRODUCT IS K983112. WE UNDERSTAND THAT THE PATIENT RECEIVED A SINGED EYEBROW AS A RESULT OF THE FIRE, HOWEVER WE WERE UNABLE TO GAIN MORE CLARITY PERTAINING TO THE PATIENT STATUS. FISHER & PAYKEL HEALTHCARE TRIED MULTIPLE TIMES TO RETRIEVE FURTHER INFORMATION FROM THE HOSPITAL REGARDING THE INCIDENT. THE AA400 THRIVE OXYGEN KIT IS INDICATED FOR USE IN THE HOSPITAL USING A CONTINUAL GAS FLOW SYSTEM PERI-INTUBATION, PERI-EXTUBATION, DURING PROCEDURAL SEDATION AND DURING POST-ANAESTHESIA CARE. IT IS INTENDED TO BE USED IN CONJUNCTION WITH THE MR810 HUMIDIFIER. THE USE OF DIATHERMY OR LASER PRESENTS A RISK OF FIRE IN THE PRESENCE OF A FUEL SOURCE SUCH AS THE PATIENT'S EYEBROW. THE USE OF SUPPLEMENTARY OXYGEN CAN INCREASE THIS RISK. SUCH RISKS HAVE BEEN WIDELY REPORTED AND WE UNDERSTAND THAT IT WAS WELL UNDERSTOOD BY OPERATING ROOM STAFF. CONSEQUENTLY, OUR USER INSTRUCTIONS CONTAIN THE FOLLOWING WARNING: "EXPOSURE TO OXYGEN INCREASES THE RISK OF FIRE. USE OF THIS SYSTEM NEAR ANY IGNITION SOURCE, INCLUDING ELECTROSURGERY, ELECTROCAUTERY, OR LASER SURGERY INSTRUMENTS MAY RESULT IN PATIENT INJURY OR DEATH." WITH REFERENCE TO THIS SPECIFIC INCIDENT, WE UNDERSTAND THAT THE HOSPITAL IS SATISFIED WITH FISHER & PAYKEL HEALTHCARE PRODUCTS AND ITS PERFORMANCE. WE UNDERSTAND THAT THE HOSPITAL IS TAKING STEPS AROUND TRAINING THEIR STAFF ABOUT OPERATING ROOM PROCEDURES TO HELP PREVENT ANY FUTURE EVENTS BUT F&P IS ADVISED THAT THE HOSPITAL DO NOT REQUIRE FURTHER PRODUCT TRAINING AS FISHER & PAYKEL HEALTHCARE HAS OFFERED. THIS CASE WAS REPORTED TO FISHER & PAYKEL HEALTHCARE BECAUSE THE THRIVE SYSTEM WAS IN USE AT THE TIME OF THE FIRE OCCURRING. THE THRIVE SYSTEM PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) REPRESENTATIVE THAT THERE WAS A PROCEDURAL SEDATION CASE IN WHICH AN OPTIFLOW THRIVE¿ SYSTEM CONSISTING OF AN AA400 AND MR810 WAS BEING USED TO PROVIDE SUPPLEMENTAL OXYGEN TO A PATIENT HAVING A LESION REMOVED FROM THEIR FOREHEAD. A DIATHERMY CAME TOO CLOSE TO THE PATIENT'S EYEBROW. THE ARC FROM THE DIATHERMY IGNITED THE AROUND ONE OF PATIENT'S EYEBROW. WE UNDERSTAND THAT THE PATIENT RECEIVED A SINGED EYEBROW. NO FURTHER PATIENT CONSEQUENCES WERE REPORTED TO FISHER & PAYKEL HEALTHCARE. THE OPTIFLOW THRIVE¿ SYSTEM OF AA400 OXYGEN KIT AND MR810 HUMIDIFIER WAS USED TO DELIVER SUPPLEMENTAL OXYGEN THROUGHOUT THE PROCEDURE, USE WAS CEASED UPON COMMENCEMENT OF THE FIRE. THERE WAS NO MALFUNCTION OF THE THRIVE SYSTEM WHICH PERFORMED AS EXPECTED. THIS CASE WAS ONLY REPORTED TO FISHER & PAYKEL HEALTHCARE BECAUSE OUR DEVICES WERE IN USE AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588011 OPTIFLOW OXYGEN KIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD AA400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other FISHER & PAYKEL HEALTHCARE MR810 HEATED HUMIDIFIER