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

Model Number PT101

Device Problems Improper Flow or Infusion (2954); Moisture or Humidity Problem (2986)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

A hospital in (b)(4) reported that while in use on a patient a pt101 airvo2 humidifier stopped giving its flow with no alarm displayed, although it did not turn off.They further reported that this was not noticed until the patient's sat's dropped and when the nurse approached there was apparently no flow coming through the machine.It was also noted that there was excessive water building up in the circuit and that the water jetted up into the patient's nose.No further patient consequence was reported.

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 complaint airvo humidifier was received at our fisher & paykel healthcare (fph) regional office in the (b)(4), where it was visually inspected and performance tested by a trained fph technician.Results: during testing the airvo operated normally and no fault was found with it.Conclusion: based on the description of events it appears likely that condensation had built up in the heated breathing tube and had pooled in the lowest part of the tube.If condensate is not cleared it could partially block the circuit, but the airvo is programmed to generate a set flow rate (as specified by the user).This means that the unit will continue to deliver the required flow, even if the resistance to flow is increased, such as by condensate in the tubing.The unit will alarm in the case of a complete blockage or if it unable to maintain the set flow rate in the case of a partial blockage.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.The subject airvo was performance tested in accordance with the product technical manual and was returned to the hospital to be put back into service.Our user instructions that accompany the airvo humidifier provide the following guidelines: - 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.The airvo 2 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 2 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.".

• 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: 4083271
• MDR Text Key: 4900353
• Report Number: 9611451-2014-00761
• 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,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2014
• 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: 140217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/17/2014
• 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