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

Model Number PT101

Device Problem Device Handling Problem (3265)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint (b)(4) heated breathing tube is expected at fisher & paykel healthcare for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that a 900pt501 adult heated breathing tube used with an airvo2 humidifier had melted while under a patient's pillow.There was no patient consequence.

Manufacturer Narrative

(b)(4).The 900pt501 adult heated breathing tube (hbt) is used with the airvo humidifier to deliver warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces.Method: the complaint 900pt501 breathing circuit was returned to fisher & paykel healthcare and was visually inspected, electrically evaluated and performance tested.The airvo humidifier that the hbt was used with remains in use at the hospital.Results: visual inspection of the complaint hbt revealed that a small section of about 180mm in length in the centre of the tubing was damaged.The tubing had melted in this section of the limb.There was no damage to the heater wire insulation, indicating that the heater wire had not produced excessive heat.The pitch of the heater wire was uniform, with no abnormalities.The resistance test showed that the heater wire of both hbts was within specification.There was no damage to the remainder of the tubing or to the connectors and heater wire pins.Conclusion: the hospital had reported that the subject hbt was under the patient's pillow for an unspecified amount of time prior to the incident.Our testing of the hbt under compressive load indicates that the tubing would have to covered and under compressive load for at least 20 to 30 minutes for any melting to occur.The heater wires are coated with teflon, which remains intact even under compressive load and has a much higher melting point than the hbt.All airvo heated breathing tubes are tested for electrical continuity on the production line.A resistance test and visual inspection is performed on the heater wire assembly after the heater wire plug has been overmoulded onto the heater wire.The user instructions that accompany the airvo humidifier contain the following warning: 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.

Event Description

A hospital in (b)(6) reported that a 900pt501 adult heated breathing tube used with an airvo2 humidifier had melted while under a patient's pillow.There was no patient consequence.

• 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: 5321198
• MDR Text Key: 34199815
• Report Number: 9611451-2015-00559
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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