MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, LTD. AIRVO2 HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number PT101US

Device Problem Defective Device (2588)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/04/2021

Event Type  Death  

Event Description

High flow o2 malfunction, no o2 delivery; sats 21%.Placed on nonrebreather with sats to 60s then on bipap with sats in 90s.We checked this hfnc device and it appeared to be functioning properly.Nurses reported no alarms or messages; however, when it was taken apart for cleaning, a small defect was found at the gas outlet.Biomed also checked and stated that it appeared the unit had been dropped or something dropped on it.It was taken out of service.Pt intubated and expired 10 days later due to covid.Fda safety report id# (b)(4).

• Brand Name: AIRVO2 HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, LTD.
• MDR Report Key: 13235972
• MDR Text Key: 283763558
• Report Number: MW5106577
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PT101US
• Device Catalogue Number: PT101US
• Device Lot Number: 2101366099
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: Black Or African American