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 Abrasion (1689)

Event Date 07/05/2018

Event Type  Injury  

Manufacturer Narrative

(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.We understand that the patient received a singed eyebrow as a result of the fire, however we were unable to gain more clarity pertaining to the patient status.Fisher & paykel healthcare tried multiple times to retrieve further information from the hospital regarding the incident.The aa400 thrive oxygen kit is indicated for use in the hospital using a continual gas flow system peri-intubation, peri-extubation, during procedural sedation and during post-anaesthesia care.It is intended to be used in conjunction with the mr810 humidifier.The use of diathermy or laser presents a risk of fire in the presence of a fuel source such as the patient's eyebrow.The use of supplementary oxygen can increase this risk.Such risks have been widely reported and we understand that it was well understood by operating room staff.Consequently, our 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." with reference to this specific incident, we understand that the hospital is satisfied with fisher & paykel healthcare products and its performance.We understand that the hospital is taking steps around training their staff about operating room procedures to help prevent any future events but f&p is advised that the hospital do not require further product training as fisher & paykel healthcare has offered.This case was reported to fisher & paykel healthcare because the thrive system was in use at the time of the fire occurring.The thrive system performed as expected.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that there was a procedural sedation case in which an optiflow thrive¿ system consisting of an aa400 and mr810 was being used to provide supplemental oxygen to a patient having a lesion removed from their forehead.A diathermy came too close to the patient's eyebrow.The arc from the diathermy ignited the around one of patient's eyebrow.We understand that the patient received a singed eyebrow.No further patient consequences were reported to fisher & paykel healthcare.The optiflow thrive¿ system of aa400 oxygen kit and mr810 humidifier was used to deliver supplemental oxygen throughout the procedure, use was ceased upon commencement of the fire.There was no malfunction of the thrive system which performed as expected.This case was only reported to fisher & paykel healthcare because our devices were in use at the time of the incident.

• 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: 7745888
• MDR Text Key: 115887431
• Report Number: 9611451-2018-00656
• 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: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2018
• 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: FISHER & PAYKEL HEALTHCARE MR810 HEATED HUMIDIFIER
• Patient Outcome(s): Other