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

Model Number 07691

Device Problems Inaccurate Flow Rate (1249); Device Displays Incorrect Message (2591)

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

Event Date 04/24/2019

Event Type  malfunction  

Event Description

Airvo was alarming.Machine could not reach set flow rate.Respiratory was not able to troubleshoot the issue.Removed from service.

• Brand Name: AIRVO
• 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: 8678346
• MDR Text Key: 147339618
• Report Number: 8678346
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/03/2019,04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 07691
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12410 DA