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 Date 12/02/2018

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 the (b)(6) reported via a fisher and paykel healthcare (f&p) representative that an incident involving pt101 airvo 2 humidifier and a third-party ups (tripplite) for transportation of a patient occurred.We were informed that during transfer of a patient from the hospital into an ambulance, the airvo unit was connected to a third-party ups via a third-party connector.The baby was on 8l/min flow and no oxygen when the transfer began however the flow was fluctuating and not remaining at 8l/min so oxygen was added.The patient desaturated down to 67%.Immediately after the event, the airvo unit was transferred from the third-party ups power supply to mains power.No further patient consequences were reported.

Manufacturer Narrative

(b)(4).The complaint pt101 airvo humidifier was returned to fisher & paykel healthcare in new zealand for evaluation.The device was performance tested.The reported fault could not be replicated and there was no fault found with the complaint device.The unit was run continuously for an extended test period.The flow was consistent at 8l/min for the entire run time.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 also states that the "airvo is for the treatment of spontaneously breathing patients who would benefit from receiving high-flow, warmed and humidified respiratory gases." finally, the user manual also warns the user: the unit is not intended for life support.Appropriate patient monitoring must be used at all times.

Event Description

A hospital in the uk reported via a fisher and paykel healthcare (f&p) representative that an incident involving pt101 airvo 2 humidifier and a third-party ups (tripplite) for transportation of a patient occurred.We were informed that during transfer of a patient from the hospital into an ambulance, the airvo unit was connected to a third-party ups via a third-party connector.The baby was on 8l/min flow and no oxygen when the transfer began however the flow was fluctuating and not remaining at 8l/min so oxygen was added.The patient desaturated down to 67%.Immediately after the event, the airvo unit was transferred from the third-party ups power supply to mains power.The patient was then transferred directly onto oxygen and adrenaline was administered.The patient recovered and the hospital proceeded with the ambulance transfer.No further patient consequences were 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
• MDR Report Key: 8187084
• MDR Text Key: 131917594
• Report Number: 9611451-2018-01091
• 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: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 2100375592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 03/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention