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

Model Number PT101

Device Problems Device Alarm System (1012); Disconnection (1171)

Patient Problems Complaint, Ill-Defined (2331); No Code Available (3191)

Event Date 10/19/2013

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that while using a pt101 airvo 2 humidifier a patient's work of breathing intermittently increased and at times the patient had "dusky lips".They reacted by increasing the oxygen, with no improvement to the patient.They then noticed that the oxygen flow meter had disconnected from the oxygen port.Hospital staff then reconnected the oxygen port.Higher oxygen and flow was given until the patient was more settled.The hospital further reported that the airvo did not alarm.

Manufacturer Narrative

(b)(4).Method: the complaint airvo humidifier was received at fisher & paykel healthcare (b)(6) and was visually inspected and performance tested at the customer settings for 24 hours with water bag attached to a water chamber for continuous water flow.The hospital had reported that the oxygen was disconnected from the oxygen port.We can conclude that the oxygen tube disconnected either from the oxygen supply or from the airvo barb connector.The hospital did not confirm what had caused the oxygen tubing to disconnect.If properly connected, the oxygen tubing fits firmly onto the barb connector and should not spontaneously disconnect.The 900pt402 oxygen inlet kit is sold as an accessory for the airvo 2 humidifier and allows the user to connect supplementary oxygen.Supplementary oxygen is connected to a barb connector, which is suitable for use with most common sizes of oxygen tubing.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." result: visual inspection revealed no damage to the airvo or to the barb connector.During testing the unit performed with no errors or warnings displayed.Oxygen readings were observed to be normal at ambient.The power fail alarm was tested and found to be functioning.Conclusion: the subject airvo operated correctly during testing.We can conclude that the patient issue was caused by the disconnection of the oxygen supply.Our user instructions that accompany the airvo humidifier state that "the airvo 2 is for the treatment of spontaneously breathing patients (adult and pediatric > 3 kg) who would benefit from receiving high flow warmed and humidified respiratory gases." they also state: "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: 4079612
• MDR Text Key: 4854611
• Report Number: 9611451-2014-00759
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K092846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• 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: 130923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2013
• 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
• Treatment: FISHER & PAYKEL 900PT402 OXYGEN INLET KIT