MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED MYAIRVO 2 HEATED BREATHING TUBE AND CHAMBER KIT; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)

Model Number 900PT561

Device Problems Device Alarm System (1012); Thermal Decomposition of Device (1071); Melted (1385); Device Emits Odor (1425)

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

Event Date 06/08/2023

Event Type  malfunction  

Event Description

Rn smelled burning from room, found airvo circuit (large opti-flow cannula, 10l 50% o2) had melted with coils exposed.Airvo device had not alarmed.Patient was unharmed.

• Brand Name: MYAIRVO 2 HEATED BREATHING TUBE AND CHAMBER KIT
• 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: 17142559
• MDR Text Key: 317309419
• Report Number: 17142559
• 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: 06/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 900PT561
• Device Catalogue Number: 900PT561
• Device Lot Number: 2101445346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/14/2023
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/16/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 2920 DA
• Patient Sex: Male
• Patient Weight: 24 KG
• Patient Race: White