MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED AIRVO; HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE

Patient Problems Dyspnea (1816); Dizziness (2194); Low Oxygen Saturation (2477)

Event Date 07/14/2023

Event Type  malfunction  

Event Description

Airvo tubing became disconnected from device, causing patient's oxygen levels to drop to 50%, and patient became dizzy and short of breath.

• Brand Name: AIRVO
• Type of Device: HIGH FLOW/HIGH VELOCITY HUMIDIFIED OXYGEN DELIVERY DEVICE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 17400 laguna canyon road., suite 300; irvine CA 92618
• MDR Report Key: 17780598
• MDR Text Key: 323830187
• Report Number: 17780598
• Device Sequence Number: 1
• Product Code: QAV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/17/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/20/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1