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

Device Problems Device Displays Incorrect Message (2591); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 07/22/2021

Event Type  malfunction  

Event Description

Alarm for fraction of inspired oxygen (fio2) had been displaying alarm message "high fio2." registered nurse called respiratory therapist (rt) because the patient stated that she could not feel flow and felt the airvo machine had shut off.Rt noted that the device was reading 10 lmp (liters per minute).

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 173 technology dr; irvine CA 92618
• MDR Report Key: 12252058
• MDR Text Key: 264311235
• Report Number: 12252058
• 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
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/22/2021
• Date Report to Manufacturer: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22265 DA