BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTIFLOW OXYGEN KIT

    MDR report key: 7604289 · Received June 15, 2018

    Report

    Report Number
    9611451-2018-00502
    Event Type
    Injury
    Date Received
    June 15, 2018
    Date of Event
    May 7, 2018
    Report Date
    May 17, 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

    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. THE CAUSE OF THIS INCIDENT WAS THE PLASTIC SHEATH OF THE ROBOTIC CAMERA ARM: THE ARM IS METAL AND THEREFORE IT APPEARED THAT THERE WAS NO FUEL IN THE AIRWAY FOR A FIRE TO OCCUR BUT FOLLOWING THE INCIDENT IT BECAME APPARENT THAT THE CAMERA ARM HAD A PLASTIC SHEATH. THE USE OF DIATHERMY OR LASER PRESENTS A RISK OF FIRE IN THE PRESENCE OF A FUEL SOURCE SUCH AS ALCOHOL SURGICAL PREPARATIONS OR DRAPES. THE USE OF SUPPLEMENTARY OXYGEN CAN INCREASE THIS RISK. SUCH RISKS HAVE BEEN WIDELY REPORTED AND ARE WELL UNDERSTOOD BY OPERATING ROOM STAFF. CONSEQUENTLY, OUR USER INSTRUCTIONS CONTAIN THE FOLLOWING WARNING: "DO NOT USE THE SYSTEM NEAR ANY IGNITION SOURCE, INCLUDING ELECTROSURGERY, ELECTROCAUTERY, OR LASER SURGERY INSTRUMENTS. EXPOSURE TO OXYGEN INCREASES THE RISK OF FIRE." WITH REFERENCE TO THIS SPECIFIC INCIDENT, COMMUNICATION WITH THE ANAESTHETIST HAS CONFIRMED THAT HE WAS AWARE THAT WHILE FISHER & PAYKEL HEALTHCARE WARNS AGAINST THE USE OF THE AA400 WITH LASER OR DIATHERMY, HE FELT IT WAS THE CORRECT TOOL TO USE IN THIS CASE. SPECIFICALLY, THE PATIENT HAD A LESION ON THE RIGHT HAND SIDE OF THE VOCAL CORDS AND THE SURGEON DID NOT WANT AN ENDOTRACHEAL TUBE IN THE WAY OF THE SURGERY. AS SUCH THE ANAESTHETIST DECIDED OUR SUPPLEMENTAL OXYGEN DELIVERY SYSTEM WAS THE BEST CLINICAL OPTION. THIS CASE WAS REPORTED TO FISHER & PAYKEL HEALTHCARE BECAUSE OUR SYSTEM WAS IN USE AT THE TIME. THE SYSTEM PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A HOSPITAL IN (B)(6) REPORTED THAT DURING AN AIRWAY CASE A DIATHERMY CAME TOO CLOSE TO A PLASTIC SHEATH ON A ROBOTIC CAMERA ARM. THE ARC FROM THE DIATHERMY IGNITED THE SHEATH. THE FIRE WAS EXTINGUISHED QUICKLY BY STAFF, WHO WERE PREPARED FOR A FIRE. THE PATIENT RECEIVED BURNS TO THE HARD PALATE. THE PATIENT WAS INTUBATED AND ADMITTED TO THE ICU IN ACCORDANCE WITH STANDARD PRACTICE FOLLOWING AIRWAY FIRES, DISCHARGED AFTER A FEW DAYS, IS RECOVERING AT HOME. AND IS EXPECTED TO MAKE A FULL RECOVERY. AN AA400 OXYGEN KIT AND MR810 HUMIDIFIER WAS USED TO DELIVER SUPPLEMENTAL OXYGEN DURING THIS INCIDENT, HOWEVER, THERE WAS NO MALFUNCTION OF THE FISHER & PAYKEL HEALTHCARE DEVICES. THE CUSTOMER COMMENTED THAT THEY ONLY REPORTED THIS CASE TO FISHER & PAYKEL HEALTHCARE BECAUSE OUR DEVICES WERE IN USE AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448608 OPTIFLOW OXYGEN KIT BTT BTT FISHER & PAYKEL HEALTHCARE LTD AA400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention FISHER & PAYKEL HEALTHCARE MR810 HUMIDIFIER