MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO2 HUMIDIFIER

Model Number PT101

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypoxia (1918)

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint airvo humidifier was returned to our fisher & paykel healthcare (fph) regional office in (b)(4) where it was inspected by a trained fph technician.The device was performance tested at the customer settings and with the same model of flow meter.The subject airvo passed all functional tests and was able to achieve 100% fio2.The hospital had stated that the airvo had displayed and sounded an alarm but were not able to tell us which alarm.Based on the description of events it is possible that the flow had become restricted due to a blockage in the breathing system.The most likely cause for this is kinking of the prongs.In this event the airvo will alarm with a "blockage" audio and visual alarm.The user should then check for any blokages in order to restore normal operation.No fault was found with the subject airvo.We have concluded that the reported incident was not caused by a malfunction of the airvo itself but possibly by a blockage in the flow delivery system, thereby restricting flow to the patient and leading to desaturation.The airvo 2 user manual provides the folllowing warnings: - do not block the flow of air through the unit and breathing tube - check the heated breathing tube or patient interface for blockage - the oxygen concentration delivered to the patient can be affected by changes to the flow setting, oxygen setting, patient interface or if the airpath is obstructed.The manual also states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases." and that "the unit is not intended for life support.".

Event Description

A hospital in (b)(6) reported that a hypoxic patient was connected to an airvo 2 humidifier, with 60lpm and fio2 at 65%.They reported that the patient desaturated from 85% to 80%; staff tried to increase the fio2 to 100% but could only achieve 85%.It was further reported that hospital staff then restarted the airvo and were able to achieve 100% fio2 with 60 lpm immediately.The patient was given an endoscopic examination of the bronchioles and there was no further impact for the patient.

• Brand Name: AIRVO2 HUMIDIFIER
• Type of Device: AIRVO2 HUMIDIFIER
• 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 5287879
• MDR Text Key: 33236343
• Report Number: 9611451-2015-00529
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 150908020174
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: FISHER & PAYKEL OPTIFLOW NASAL CANNULA