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

Model Number 900PT561

Device Problem Melted (1385)

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

Event Date 05/10/2022

Event Type  malfunction  

Event Description

Staff found high flow device circuit (tubing) was melted on patient's bed.Signs of the heat marks on the side of the bed.Suspected tubing may have become trapped in the side rail and was being pinched up against the bed.Pinch may have led to pressure buildup of heat which could have caused circuit to melt.No patient contact therefore no injury to patient.Concern for potential burns/fire.The high flow unit was removed from service and sent to biomed for review and vendor was notified of the event.

• Brand Name: MYAIRVO 2 HEATED BREATHING TUBE AND CHAMBER KIT
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): FISHER & PAYKEL LIMITED HEALTHCARE; 17400 laguna canyon road; suite 300; irvine CA 92618
• MDR Report Key: 14694766
• MDR Text Key: 294041354
• Report Number: 14694766
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• 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: 2101249702 OR 2101308307
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2022
• Date Report to Manufacturer: 06/15/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13505 DA