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

Model Number PT101

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint airvo humidifier was not returned to fisher & paykel healthcare (fph) for evaluation as it continues to be used by the hospital.The hospital confirmed that the airvo correctly alarmed to inform staff that the set oxygen levels had dropped.Conclusion: the 900pt402 oxygen inlet kit is supplied with the airvo 2 humidifier and allows the user to connect supplementary oxygen via a barb connector, which is suitable for use with most common sizes of oxygen tubing.The hospital did not confirm what had caused the oxygen tubing to become disconnected.No failure of the subject airvo 2 was alleged and we can conclude that it continues to deliver therapy as intended.The airvo user manual 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." 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 airvo 2 product technical manual informs the user how to set the low oxygen alarm and states: "when set to 25% the unit will alarm if the measured oxygen fraction is below this value.This allows detection of oxygen being disconnected.".

Event Description

A hospital in (b)(6) reported that a patient with influenza was being treated with 60% oxygen on an airvo 2 humidifier.The airvo and the patient monitor both alarmed to alert staff and it was noted that the patient oxygen saturation had dropped to 50%.It was found that the oxygen tube had become disconnected from the wall oxygen flow meter.Once the oxygen tube was reconnected, the patient condition improved and there was no further consequence 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6262682
• MDR Text Key: 65210555
• Report Number: 9611451-2017-00018
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/20/2016

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?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/20/2016
• Initial Date FDA Received: 01/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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