BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLOW OXYGEN KIT

    MDR report key: 8485585 · Received April 4, 2019

    Report

    Report Number
    9611451-2019-00316
    Event Type
    Injury
    Date Received
    April 4, 2019
    Report Date
    March 8, 2019
    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 OPTIFLOW THRIVE SYSTEM 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. THE OPTFILOW THRIVE SYSTEM IS INDICATED FOR USE IN THE HOSPITAL DURING PERI-INTUBATION, PERI-EXTUBATION, PROCEDURAL SEDATION AND POST-ANAESTHESIA CARE. IT IS INTENDED TO BE USED IN CONJUNCTION WITH THE MR810 HUMIDIFIER TO DELIVER HUMIDIFIED OXYGEN. IN THE REPORTED EVENT, THE CUSTOMER STATED THAT WHILE THE DIATHERMY UTILIZED BIOPSY WAS BEING PERFORMED, A FIRE WAS STARTED WHEN THE DIATHERMY NEEDLE MADE CONTACT WITH A PIECE OF GAUZE ON THE PATIENT'S FACE. THE FIRE WAS EXTINGUISHED QUICKLY. THE CLINICIAN THOUGHT THAT REDUCING OXYGEN FLOW MAY REDUCE THE RISK OF FIRE AND SUBSEQUENTLY REDUCED THE FLOW OF THE OXYGEN THROUGH THE NASAL INTERFACE, AS THE BENEFITS OF USING NASAL HIGH-FLOW OUTWEIGHED THE RISKS RELATIVE TO THE ALTERNATIVES. IT IS UNKNOWN WHETHER ANY ALCOHOL SKIN PREPARATION HAD BEEN UTILIZED. THIS CASE WAS REPORTED TO FISHER & PAYKEL HEALTHCARE BECAUSE THE OPTIFLOW THRIVE SYSTEM WAS IN USE AT THE TIME OF THE FIRE OCCURRING. THE OPTFILOW THRIVE SYSTEM PERFORMED AS EXPECTED. A FISHER & PAYKEL HEALTHCARE FIELD REPRESENTATIVE DIRECTLY CONTACTED THE CUSTOMER AFTER THE REPORTED EVENT WAS RECEIVED TO ARRANGE FURTHER TRAINING ON THE CORRECT USE AND SETUP OF THE OPTIFLOW THRIVE SYSTEM. CONSEQUENTLY, OUR OPTIFLOW THRIVE SYSTEM 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."

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) (CUSTOMER) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT DURING A DIATHERMY UTILIZED LIP EXCISION BIOPSY, A FIRE WAS INITIATED WHEN THE DIATHERMY NEEDLE MADE CONTACT WITH A PIECE OF GAUZE ON THE PATIENT'S FACE CAUSING THE GAUZE TO BE ALIGHT. THE FIRE WAS EXTINGUISHED QUICKLY. THE PATIENT RECEIVED SUPERFICIAL BURNS TO THE LIP AND THIRD DEGREE BURNS TO THE BACK OF THE NECK. THE PATIENT WAS LATER REPORTED BEING DISCHARGED AFTER THE BURNS WERE TREATED. AN AA400 OXYGEN KIT (OPTIFLOW THRIVE SYSTEM) AND AN MR810 HUMIDIFIER WERE USED TO DELIVER SUPPLEMENTAL OXYGEN DURING THIS INCIDENT. THE CUSTOMER COMMENTED THAT THEY ONLY REPORTED THIS CASE TO FISHER & PAYKEL HEALTHCARE BECAUSE THE OPTIFLOW THRIVE SYSTEM WAS IN USE AT THE TIME AND THAT THERE WAS NO MALFUNCTION WITH THE OPTIFLOW THRIVE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277667 OPTIFLOW OXYGEN KIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD AA400 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Other