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

Model Number PT101

Device Problem Device Handling Problem (3265)

Patient Problem Low Oxygen Saturation (2477)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of retrieving further information and complaint airvo pt101 device from the hospital.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that a pt101 airvo 2 humidifier knocked into bed during line removal and the patient connected to the airvo desaturated to 65%.The patient was put onto face mask oxygen immediately to recover the desaturation.No further patient consequences were reported.

Event Description

A hospital in the uk reported that a pt101 airvo 2 humidifier knocked into bed during line removal and the patient connected to the airvo desaturated to 65%.The patient was put onto face mask oxygen immediately to recover the desaturation.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).Following this complaint, we sought further information from the hospital.We were informed that the nurse was removing a central line from the neck whilst patient was lying flat, airvo 2 device was between two pendants (patient bed and electrical pendant).During line removal, the machine was knocked and the filter holder came undone at the back of the airvo2 device.We were further informed that patient desaturated down to 65%, however was put onto face mask oxygen immediately to recover the desaturation.No further patient consequences were reported.Conclusion: we were unable to gain in-depth information pertaining to the incident from the hospital.Specifically, we were not informed about the circumstances which would explain "how" the filter holder came undone.The airvo 2 device was also not returned to fisher & paykel healthcare for further investigation.We are unable to determine what caused the reported patient desaturation.It is possible that the desaturation was related to the patient condition.Please note the airvo 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 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.".

• 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
• MDR Report Key: 8098080
• MDR Text Key: 128410737
• Report Number: 9611451-2018-00990
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• PMA/PMN Number: K131895
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2018

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: 171204
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/21/2018
• Supplement Dates Manufacturer Received: 10/23/2018
• Supplement Dates FDA Received: 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1