MAUDE Adverse Event Report: FISHER AND PAYKEL HEALTHCARE, INC. AIRVO 2 HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS

Model Number PT101US

Device Problems No Display/Image (1183); Inaccurate Delivery (2339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/15/2018

Event Type  malfunction  

Event Description

The airvo high flow device had a yellow screen with a fault error.It was not delivering any oxygen or flow.The cabg patient needed high flow.The patient was placed on bipap while a new device was obtained.There was no harm to the patient.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS
• Manufacturer (Section D): FISHER AND PAYKEL HEALTHCARE, INC.; 173 technology dr; irvine CA 92618
• MDR Report Key: 8267263
• MDR Text Key: 133739103
• Report Number: 8267263
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/27/2018,12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PT101US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2018
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Weight: 86