BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTIFLOW FILTERED NASAL INTERFACE

    MDR report key: 21360994 · Received February 11, 2025

    Report

    Report Number
    9611451-2025-00069
    Event Type
    Malfunction
    Date Received
    February 11, 2025
    Report Date
    January 13, 2025
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE AA001M OPTIFLOW FILTERED NASAL INTERFACE IS NOT SOLD IN THE USA BUT IS CONSIDERED SIMILAR TO PRODUCTS SOLD IN THE USA. THE 510(K) FOR THESE PRODUCTS IS K201723. METHOD: THE SUBJECT AA001 OPTIFLOW FILTERED NASAL INTERFACE WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT AND ITS PROPER USE. RESULTS: THE HEALTHCARE FACILITY REPORTED THAT A FIRE OCCURRED WHILE NASAL HIGH FLOW OXYGEN WAS ADMINISTERED DURING A FACIAL BI-POLAR DIATHERMY PROCEDURE. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT WAS PROVIDED WITH BASIC FIRST AID DUE TO SWELLING OF THE PATIENT'S LIP, BURNS TO THE NOSTRILS AND A RED MARK UP THE NOSE AND CENTRAL FOREHEAD AS A RESULT OF THE EVENT. THE HEALTHCARE FACILITY ALSO REPORTED THAT NO FURTHER MEDICAL INTERVENTION WAS NECESSARY, AND NO LONG-TERM CONSEQUENCES ARE ANTICIPATED. THE HEALTHCARE FACILITY REPORTED THAT THE EVENT WAS SOLELY ATTRIBUTABLE TO THE USER AND THAT THE AA001M OPTIFLOW FILTERED NASAL INTERFACE WAS NOT RESPONSIBLE FOR CAUSING THE EVENT. THE HEALTHCARE FACILITY REPORTED THAT THEY HAVE IMPLEMENTED NEW STANDARD OPERATING PROCEDURES. CONCLUSIONS: THE USE OF ELECTROCAUTERY FOR THE HEAD AND NECK IS CONTRAINDICATED FOR THE F&P OPTIFLOW FILTERED NASAL INTERFACE IN THE USER INSTRUCTIONS SUPPLIED WITH THE DEVICE. THE HEALTHCARE FACILITY REPORTED THAT THE EVENT WAS SOLELY ATTRIBUTABLE TO THE USER AND THAT THE AA001M OPTIFLOW FILTERED NASAL INTERFACE WAS NOT RESPONSIBLE FOR CAUSING THE EVENT. ADDITIONALLY, THE HEALTHCARE FACILITY REPORTED THAT THEY HAVE IMPLEMENTED NEW STANDARD OPERATING PROCEDURES, AND A F&P FIELD REPRESENTATIVE IS SCHEDULED TO CONDUCT ADDITIONAL TRAINING WITH THE HEALTHCARE FACILITY STAFF. THE OPTIFLOW FILTERED NASAL INTERFACE IS A NASAL INTERFACE THAT DELIVERS RESPIRATORY GASES TO ADULT PATIENTS IN HOSPITALS AND MEDICAL FACILITIES. BASED ON THE INFORMATION PROVIDED BY THE HEALTHCARE FACILITY, ALL THREE ASPECTS OF THE FIRE TRIANGLE (FUEL, OXIDIZER AND IGNITION) WERE PRESENT IN THIS INCIDENT. THE USER INSTRUCTIONS SUPPLIED WITH THE OPTIFLOW FILTERED NASAL INTERFACE STATE THE FOLLOWING: THE FOLLOWING ARE CONTRAINDICATED FOR THE OPTIFLOW FILTERED NASAL INTERFACE. FAILURE TO COMPLY CAN LEAD TO SERIOUS INJURY OR DEATH. CONTRAINDICATION: DO NOT USE THIS PRODUCT WITH ELECTROSURGERY OR ELECTROCAUTERY DEVICES ON THE HEAD OR NECK. REFER TO THE FIRE DANGER INFORMATION. FIRE DANGER: THIS PRODUCT IS AN OPEN OXYGEN DELIVERY SYSTEM. OPEN OXYGEN DELIVERY CAN INCREASE THE RISK OF A SURGICAL FIRE OCCURRING, CAUSING SERIOUS INJURY OR DEATH. EXTREME CARE MUST BE TAKEN. THE FOLLOWING IS ADVISED. WARNING: DO NOT USE THIS PRODUCT WHERE IGNITION SOURCES AND FUEL ARE PRESENT. USE WITH IGNITION SOURCES AND FUEL PRESENT COMPLETES THE FIRE TRIANGLE, INCREASING THE RISK OF FIRE. THE FOLLOWING STEPS SHOULD BE TAKEN TO REDUCE THE RISK OF A SURGICAL FIRE OCCURRING: ENSURE GAS FLOW FROM THE PRODUCT IS NOT IN OR NEAR THE SURGICAL FIELD AND THE SURGICAL SITE IS FREE OF A POTENTIAL FUEL SOURCE, INCLUDING ALCOHOL SKIN PREPARATION, GAUZE, SPONGES AND DRAPES BEFORE POTENTIAL IGNITION SOURCES, SUCH AS ELECTROSURGERY, ELECTROCAUTERY OR LASER DEVICES ARE USED. ENSURE THE ROOM IS ADEQUATELY VENTILATED AS OXYGEN MAY ACCUMULATE OVER TIME.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN THE UNITED KINGDOM REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT NASAL HIGH FLOW OXYGEN WAS ADMINISTERED USING AN AA001M OPTIFLOW FILTERED NASAL INTERFACE DURING A BI-POLAR DIATHERMY PROCEDURE IN WHICH IT WAS REPORTED THAT A FIRE HAD TAKEN PLACE. THE HEALTHCARE FACILITY REPORTED THAT THE EVENT WAS SOLELY ATTRIBUTABLE TO THE USER AND THAT THE AA001M OPTIFLOW FILTERED NASAL INTERFACE WAS NOT RESPONSIBLE FOR CAUSING THE EVENT. THE HEALTHCARE FACILITY REPORTED THAT THE PATIENT WAS PROVIDED WITH BASIC FIRST AID DUE TO SWELLING OF THE PATIENT'S LIP, BURNS TO THE NOSTRILS AND A RED MARK UP THE NOSE AND CENTRAL FOREHEAD AS A RESULT OF THE EVENT. THE HEALTHCARE FACILITY ALSO REPORTED THAT NO FURTHER MEDICAL INTERVENTION WAS NECESSARY, AND NO LONG-TERM CONSEQUENCES ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042798 OPTIFLOW FILTERED NASAL INTERFACE NASAL INTERFACE BTT FISHER & PAYKEL HEALTHCARE LTD AA001M

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male