MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC. AIRVO 2; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Catalog Number 2100933024

Device Problems Therapeutic or Diagnostic Output Failure (3023); Unexpected Shutdown (4019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 05/29/2021

Event Type  malfunction  

Event Description

The writer was called to room to access a patient who was experiencing oxygen desaturation issues.The nurse caring for the patient suspected the airvo high flow device might be off.Upon arrival, the writer noticed a monitor oxygen saturation of 87 percent.After investigation of the machine and securing all connections on the device by the writer, the machine seemed to be on and working and the patient¿s oxygen status seemed to improve.Approximately 45 minutes later, the writer was called again due to the same issue.Upon arrival, an oxygen saturation of 75 percent was seen via monitor.After open deep suctioning and a trach inner cannula change, the patient was placed on a 15 liter oxymask.The patient¿s oxygen status quickly improved with an oxygen saturation of 100 percent.After investigation of the machine for the second time, the writer suspects the machine shut off by itself.The machine was then taken out of service.The patient received an optiflow device instead of the airvo high flow.Before leaving, bilateral breath sounds were heard upon auscultation and the patient did not show any signs of respiratory distress.

• Brand Name: AIRVO 2
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.; 173 technology dr; irvine CA 92618
• MDR Report Key: 12092100
• MDR Text Key: 259158438
• Report Number: 12092100
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 2100933024
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26280 DA
• Patient Weight: 67