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

Model Number AIRVO 2

Device Problems No Device Output (1435); Device Displays Incorrect Message (2591)

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

Event Date 08/25/2018

Event Type  malfunction  

Event Description

While connected to patient, the device stopped delivering flow.The settings were fio2 40%, 35 lpm, temp 34.Error code visualized by nursing staff and reported as error code 541.They possibly misread the error code number as that code does not exist.

• Type of Device: HUMIDIFIER, RESPIRATORY GAS, INTERFACE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE; 173 technology dr; irvine CA 92618
• MDR Report Key: 7900321
• MDR Text Key: 121565732
• Report Number: 7900321
• 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: 27375 DA