MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE, INC.; HUMIDIFIER, RESPIRATORY GAS, INTERFACE

Model Number AIRVO 2

Device Problems No Device Output (1435); Failure to Deliver (2338)

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

Event Date 08/24/2018

Event Type  malfunction  

Event Description

While connected to a patient, the device stopped delivering flow.The only flow felt was what was dialed in on the flowmeter.There was no heat coming out the other end, and no visual or audible alarm.Tried turning off and turning back on but that did not help.

• Type of Device: HUMIDIFIER, RESPIRATORY GAS, INTERFACE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE, INC.; 173 technology dr; irvine CA 92618
• MDR Report Key: 7900322
• MDR Text Key: 121565706
• Report Number: 7900322
• 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: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AIRVO 2
• 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: 09/11/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 32120 DA