MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW OXYGEN KIT; BTT

Model Number AA400

Device Problems Fire (1245); Human-Device Interface Problem (2949)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Type  Injury  

Manufacturer Narrative

(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.".

Event Description

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.

• Brand Name: OPTIFLOW OXYGEN KIT
• Type of Device: BTT
• 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 8485585
• MDR Text Key: 141006864
• Report Number: 9611451-2019-00316
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AA400
• Device Catalogue Number: AA400
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 04/04/2019
• 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
• Patient Outcome(s): Other