MAUDE Adverse Event Report: VYAIRE MEDICAL IFLOW; SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Model Number 301.328.020

Device Problems Break (1069); Disconnection (1171)

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

Event Date 12/06/2022

Event Type  malfunction  

Event Description

Device snapped and led to a disconnect between endotracheal tube and ventilator.

• Brand Name: IFLOW
• Type of Device: SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 16102100
• MDR Text Key: 306697130
• Report Number: 16102100
• Device Sequence Number: 1
• Product Code: BZO
• 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: 12/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 301.328.020
• Device Catalogue Number: 301.328.020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/14/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18250 DA
• Patient Sex: Male