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

Model Number PT100

Device Problem Melted (1385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint devices are currently en route to fisher and paykel healthcare for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in sweden reported that the heated breathing tube (hbt) of a pt100 myairvo 2 humidifier had partly melted at the chamber end while in use on a home care patient.It was reported that the hbt was changed on (b)(6) 2015 and at 4 o'clock on the night of(b)(6) 2015, when the caregiver was connecting the tube, they noticed that the tube had melted into the sheets/pillow.They turned off the airvo and took away the tube and the patient slept without treatment.Another tube was used the next night and in the morning there were visible spots of melting also on this tube.The healthcare facility stated that the tube was lying loose in the bed but was sometimes placed under the blanket for short intervals.No patient consequence was reported.

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 airvo humidifier and two 900pt501 breathing circuits were returned to fisher & paykel healthcare and were visually inspected.The airvo was performance tested using a known good hbt.The heater wire of both the returned complaint hbts was resistance tested using a calibrated mutlimeter.Results: performance testing of the airvo indicated that the device was functioning correctly.At the end of the test there was no damage to the hbt and no malfunction of the airvo.Visual inspection of the complaint hbts revealed that a small section of tubing about 40-50mm from the patient end connector 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 hbts were under the patient's blankets 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 provide 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.The user manual instructs the user to "use continuous oxygen monitoring on patients who would desaturate significantly in the event of disruption to their oxygen supply." the user 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 healthcare facility in (b)(6) reported that the heated breathing tube (hbt) of a pt100 myairvo 2 humidifier had partly melted at the chamber end while in use on a home care patient.It was reported that the hbt was changed on (b)(6) 2015 and at 4 o'clock on the night of (b)(6) 2015, when the caregiver was connecting the tube, they noticed that the tube had melted into the sheets/pillow.They turned off the airvo and took away the tube and the patient slept without treatment.Another tube was used the next night and in the morning there were visible spots of melting also on this tube.The healthcare facility stated that the tube was lying loose in the bed but was sometimes placed under the blanket for short intervals.No patient consequence was reported.

• 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: 5113853
• MDR Text Key: 27307587
• Report Number: 9611451-2015-00423
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 08/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT100
• Device Catalogue Number: PT100
• Device Lot Number: 130925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2013
• 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