MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED AIRVO 2 HUMIDIFIER; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number PT101US

Device Problems Circuit Failure (1089); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2022

Event Type  malfunction  

Event Description

Error message appeared on airvo 2 while on patient.Error message said to change breathing circuit and restart machine.Changed circuit and restarted machine.Check mark appeared on machine indicating that it is now properly functioning.

• Brand Name: AIRVO 2 HUMIDIFIER
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 17400 laguna canyon road., suite 300; irvine CA 92618
• MDR Report Key: 16093896
• MDR Text Key: 306628503
• Report Number: 16093896
• 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: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PT101US
• Device Catalogue 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: 12/13/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 01/04/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 510 DA
• Patient Sex: Female