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

Model Number PT101

Device Problem Moisture or Humidity Problem (2986)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that while using the pt101 airvo2 humidifier there was excessive condensation and "rain out shot up [the] patient's nose".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.Method: the 900pt531 adult heated breathing tube (hbt) that was in use with the complaint airvo humidifier was received at fisher & paykel healthcare (fph) (b)(4).The returned hbt was visually inspected and connected to a working airvo set up with water bag and an mr290 chamber.The airvo with the returned hbt unit was powered up and test run for four hours.The complaint airvo humidifier is not expected to be returned for evaluation.There was no actual defect alleged and the hospital continues to use the subject airvo.Results: during testing the returned breathing tube warmed within five minutes and operated normally for the duration of the test.Only light condensation in the form of droplets was noted on the inner surface of the tube.The customer complaint could not be replicated.Conclusion: no fault was found with the complaint hbt and the hospital continues to use the airvo.Condensate in the humidification system, although not preferred, is an expected side effect of heated pass-over humidification systems in many conditions, and may vary between light misting to water droplets that form on the wall of cool breathing circuit tubing.The amount of condensate in the ventilation system is influenced by multiple setup and environmental factors.Following this incident an fph representative provided additional training and guidance on condensate management to hospital staff.Our user instructions that accompany the airvo humidifier provide the following guidelines: - do not use the unit when the room temperature exceeds 30 degc (86 degf) or is below 10 degc (50 degf) as the unit may switch off.Humidity output will be compromised below 18 degc (64 degf) and above 28 degc (82 degf).- if excess condensation accumulates in the heated breathing tube, drain by lifting the patient end of the tube, allowing the condensate to run into the water chamber.

• 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: 4052826
• MDR Text Key: 4909429
• Report Number: 9611451-2014-00745
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: Physical Therapist
• Type of Report: Initial
• Report Date: 08/08/2014

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 09/02/2014
• 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