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

Model Number PT101

Device Problem Reset Problem (3019)

Patient Problems Burn(s) (1757); Erythema (1840)

Event Date 09/22/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that a (b)(6) was being treated with an airvo2 humidifier.The heated breathing tube of the airvo was resting against his upper body for about 10 to 15 minutes and his skin reddened (the infant was unclothed).After an hour the redness subsided and only a small area appeared to have a slight burn.There was no further 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 communicated with the hospital in order to obtain further information and to obtain an update regarding the injury to the (b)(6).The hospital confirmed that the (b)(6)'s skin had healed apart from one small burn.Method: after the incident the hospital continued to use the airvo humidifier without issue.However at our request they returned it to fisher & paykel healthcare (b)(4) for testing.The airvo and heated breathing tube were visually inspected and performance tested.Airvo humidifier test results: the subject airvo was tested in accordance with the airvo technical manual and was found to be functioning correctly.It was noted that the speaker was not functioning, but this would not have had any bearing on the incident.The 900pt531 heated breathing tube test results: visual inspection of the complaint breathing tube revealed no defects.During performance testing the tube operated within the normal temperature range.Tests conducted on the returned heated breathing tube revealed that the surface temperature reached a maximum of 39.3° celsius.Conclusion: the devices were operating normally.The injury to the baby has occurred due to the baby's skin being in direct contact with the tube for a lengthy time.The airvo system complies with the iso 8185 and iec 60601 standards.The surface temperature of the heated breathing tube is within the limits specified by iso 8185 with regard to hot tube surface temperature not exceeding 44° celsius.Our user instructions that accompany the airvo humidifier state: do not allow the breathing tube to remain in direct contact with skin for a prolonged period of time an fph representative followed up with the hospital and additional training has been provided to the staff, with an assurance that this will not happen again.

• 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: 4191402
• MDR Text Key: 4986093
• Report Number: 9611451-2014-00825
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/22/2014

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
• Device Lot Number: 140513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/22/2014
• Initial Date FDA Received: 10/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/13/2014
• 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 OPT318 OPTIFLOW JUNIOR CANNULA
• Patient Age: 3 MO