MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD AIRVO 2 HUMIDIFIER

Model Number PT101

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Respiratory Distress (2045)

Event Date 07/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint device is currently en route to fisher & paykel healthcare (b)(4) (f&p) for evaluation.We are currently investigating if our product have caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via fisher & paykel healthcare (f&p) field representative of an incident involving pt101 airvo 2 humidifier.It was reported that the airvo device "stopped ventilating" and the patient had a sudden and severe desaturation leading to respiratory distress, agitation and anxiety.As a result, the patient was intubated for ventilation.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).Amended b1 to untick "product problem", as no malfunction was found with device.Method: the complaint pt101 airvo 2 humidifier was returned to fisher & paykel healthcare (f&p) new zealand for evaluation where it was visually inspected and functionally tested by trained f&p personnel.Further information was requested from the healthcare facility.Results: no further information was provided by the healthcare facility.The complaint device was functionally tested at 60lpm for 4 hours while monitoring the flow.No flow related issues and no errors or alarm warnings were generated.The reported fault was not replicated.The unit was opened and inspected and no evidence of a fault was found.Upon checking the fault log on the date of reported event, the "check tube" and "check for blockage" alarms were recorded.Conclusion: we are unable to conclusively determine the cause of the reported event.Based on our analysis of the device, the complaint device airvo 2 humidifier performed as expected and no fault was found.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 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.".

Event Description

A healthcare facility in france reported via fisher & paykel healthcare (f&p) field representative of an incident involving pt101 airvo 2 humidifier.It was reported that the airvo device "stopped ventilating" and the patient had a sudden and severe desaturation leading to respiratory distress, agitation and anxiety.As a result, the patient was intubated for ventilation.No further patient consequence was reported.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: AIRVO 2 HUMIDIFIER
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LTD; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• MDR Report Key: 8948183
• MDR Text Key: 160725410
• Report Number: 9611451-2019-00828
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012422286
• UDI-Public: (01)09420012422286(10)2100543173(11)180730
• 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: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101
• Device Catalogue Number: PT101
• Device Lot Number: 2100543173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 09/14/2019
• Supplement Dates FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention