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

Device Problems Failure to Power Up (1476); No Flow (2991)

Patient Problem Insufficient Information (4580)

Event Date 12/31/2020

Event Type  malfunction  

Event Description

Writer entered room to check airvo high flow oxygen system for 1900 round.On examination, writer determined device was not turning on and no flow or supplemental oxygen was reaching patient.On interview with rn, rn stated she "heard a beep from the device when she was in the room" but was unable to give an exact time.Patient was not transported from sicu on device prior to admittance to 7cfac.Pulse oximeter was on and reading 97% on room air and patient was not in distress.Respiratory rate 16.Writer placed oxymask with 5l on patient.Original plan of care was to wean patient slowly off device throughout the night shift and transition to oxymask in morning.

• Brand Name: AIRVO 2
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 173 technology dr; irvine CA 92618
• MDR Report Key: 11306930
• MDR Text Key: 231151138
• Report Number: 11306930
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/04/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/10/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31755 DA