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

Catalog Number PT101US

Device Problems No Display/Image (1183); Protective Measures Problem (3015)

Patient Problem Low Oxygen Saturation (2477)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

Respiratory (rt) called to room due to patient oxygen desaturation.The therapist maxed out the heated high flow setting on the airvo.Machine checked to ensure it was maxed out and it was noted that the screen was black.The power button was pressed and showed an error that read "fault e195".Rt(respiratory therapist) leadership met with fisher and paykel representative.Per the rep, the airvo does not have an auto shut off feature.The unit would have to completely fail.It was determined that oxygen was flowing but the screen was black, giving the impression it had shut off.

• Brand Name: FISHER AND PAYKEL HEALTHCARE AIRVO2
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED
• MDR Report Key: 16446520
• MDR Text Key: 310369467
• Report Number: MW5115238
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PT101US
• Device Lot Number: 2100289817
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American