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

Model Number AA400SU

Device Problem Use of Device Problem (1670)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 01/14/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The optiflow oxygen kit is intended to deliver respiratory gases.It is indicated for use with fisher & paykel healthcare (f&p) mr810 respiratory humidifier.Method: the complaint device aa400su was not returned to fisher & paykel healthcare for evaluation.Our investigation is based on the information provided by the customer and our knowledge of the product.Results: the hospital reported that the device was connected to the patient with oxygen flow of 60lpm while the humidifier was switched off for 17minutes.This resulted in oxygen gas without humidity being delivered to the patient.Conclusion: based on the information provided by the hospital, we can conclude that the aa400su did not cause the reported event.The root cause of the reported event is likely to be due to user error.The hospital reported that the humidifier was not turned on during the reported event, resulting in no humidification of the gas flow delivered to the patient.The user instructions accompanying the optiflow oxygen kit states the following: fill the chamber with water.Use usp sterile water for inhalation or equivalent.For use with the mr810 humidifier only.Turn on the humidifier, set to heat level 3 and plug in the heated tubing.Monitor chamber water level.Refill when necessary.100ml of water provide humidity for up to 60 minutes.Appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative of a patient incident involving aa400su optiflow oxygen kit.The aa400su was connected to the anesthetised patient with oxygen flow of 60 lpm, however the respiratory humidifier was not powered on.The humidifier was discovered to be powered off after 17 minutes.As a result, it was reported that the patient's nasal passages were swollen and obstructed , and they experienced pain, ear plugging and swollen tear ducts for several weeks following the procedure.No further patient consequences were reported.

• 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
• MDR Report Key: 9970667
• MDR Text Key: 190623306
• Report Number: 9611451-2020-00374
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K033008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 01/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AA400SU
• Device Catalogue Number: AA400SU
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2020
• 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): Required Intervention