MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW NASAL CANNULA INTERFACE; CCK

Model Number AA031M

Device Problems Off-Label Use (1494); Smoking (1585); Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of investigation.

Event Description

A healthcare facility in australia reported via fisher & paykel healthcare (f&p) field representative that smoke was noticed whilst using the aa031m optiflow nasal cannula during monopolar diathermy, causing a singed eyebrow and a red forehead.The patient was provided soothing cream and was discharged as intended with no delay.No further patient consequence was reported.It was further reported that there was no malfunction with the device and the healthcare facility noted they used the aa031m optiflow nasal cannula incorrectly against the user instruction.The user instructions contain the following contraindication: "do not use this product with electrosurgery or electrocautery devices on the head or neck", contraindicating the use of the cannula during diathermy - a form of electrocautery.

Manufacturer Narrative

(b)(4).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 950 humidifier to deliver humidified oxygen.Method: the complaint aa031 optiflow nasal cannula was not returned to fisher & paykel (f&p) healthcare in new zealand for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that they were using an aa031 optiflow nasal cannula on a patient whilst they were having a skin cancer removed from the forehead via monopolar diathermy.The healthcare facility noticed smoke but no flames from the patient's forehead.As a result, the patient had a singed eyebrow and a red forehead.Soothing cream was applied to the patient's forehead.The patient was discharged as intended with no delay.Our user instructions contain the following warnings: "do not use this product with electrosurgery or electrocautery devices on the head or neck" and "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".Diathermy is a form of electrocautery.All three aspects of the fire triangle (fuel, oxidizer and ignition) were present in this incident.Human tissue provided the fuel, the patient was supplied 100% oxygen, providing the oxidizer, and the ignition was the electrical current in the diathermy needle.Conclusion: the use of diathermy with the aa031m optiflow nasal cannula is against user instructions.The use of diathermy devices presents a significant risk of fire in the presence of a fuel source.The use of supplementary oxygen can increase this risk.This risk is generally well understood by operating room staff.The hospital confirmed that they were aware of the warnings in our user instructions and that there was no malfunction of the interface, it performed as expected.However, the hospital has been reminded about the user instructions and the correct use and setup of the optiflow thrive system.

Event Description

A healthcare facility in australia reported via fisher & paykel healthcare (f&p) field representative that smoke was noticed whilst using the aa031m optiflow nasal cannula during monopolar diathermy, causing singed eyebrows and a red forehead.The patient was provided soothing cream and was discharged as intended with no delay.No further patient consequence was reported.It was further reported that there was no malfunction with the device and the healthcare facility noted they used the aa031m optiflow nasal cannula incorrectly against the user instruction.The user instructions contain the following contraindication: "do not use this product with electrosurgery or electrocautery devices on the head or neck", contraindicating the use of the cannula during diathermy - a form of electrocautery.

• Brand Name: OPTIFLOW NASAL CANNULA INTERFACE
• Type of Device: CCK
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer Contact: faranak gomarooni ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494534000
• MDR Report Key: 14049256
• MDR Text Key: 296749087
• Report Number: 9611451-2022-00233
• Device Sequence Number: 1
• Product Code: CCK
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K201723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AA031M
• Device Catalogue Number: AA031M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: F&P 950 RESPIRATORY HUMIDIFER; F&P 950 RESPIRATORY HUMIDIFER; F&P AA451 OPTIFLOW OXYGEN KIT; F&P AA451 OPTIFLOW OXYGEN KIT
• Patient Outcome(s): Other