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

Model Number PT101

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2015

Event Type  malfunction  

Event Description

A hospital in ireland reported that an infant patient was using an airvo2 humidifier and the tubing was covered with a blanket.When the blanket was removed the following morning it was found that the tubing had melted.There was no patient consequence.

Manufacturer Narrative

(b)(4).The airvo is a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.Following this incident a fisher & paykel healthcare (fph) representative visited the hospital in order to obtain further information.The hospital stated that the complaint circuit had already been thrown away and was thus unavailable for evaluation.Our representative reiterated that the circuit should not be covered as per our user instructions.The hospital confirmed that they are aware of this and that it is standard protocol to leave the circuit uncovered.This was simply an oversight on their part in this instance.The airvo humidifier was not returned as there was no malfunction and the hospital continues to use it.Production samples of the same type as the complaint circuit have been tested using the same operating conditions as those reported by the hospital.Additional performance tests were carried out in which the breathing tubes were tested doubled over on themselves, kinked or crushed.Test tubes were also covered with insulative material to simulate the breathing tube being placed under bedding.Our testing has shown that across all normal operating conditions, the breathing tube is not able to melt.During testing under a covering the tubing did not melt unless it was both doubled over and under compressive load.Our user instructions that accompany the airvo humidifier provides the following guideline: adding heat, above ambient levels, to any part of the breathing tube or interface, e.G.Covering with a blanket, or heating it in an incubator or overhead heater for a neonate, could result in serious injury.

• 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: 4509613
• MDR Text Key: 5493816
• Report Number: 9611451-2015-00075
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/13/2015
• Initial Date FDA Received: 02/11/2015
• 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: Reuse
• Patient Sequence Number: 1
• Treatment: FISHER & PAYKEL OPT314 NEONATAL CANNULA