MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. VITAL SIGNS; AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY

Model Number 3590

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/13/2020

Event Type  malfunction  

Event Description

During intubation with oral airway small piece of yellow plastic slid out of the oral airway into the patient's pharynx.This was noted by the anesthesia student and removed with magill forceps prior to case start preventing harm to the patient.

• Brand Name: VITAL SIGNS
• Type of Device: AIRWAY, OROPHARYNGEAL, ANESTHESIOLOGY
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 n. riverwoods blvd; mettawa IL 60045
• MDR Report Key: 10441775
• MDR Text Key: 204020610
• Report Number: 10441775
• Device Sequence Number: 1
• Product Code: CAE
• 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: 08/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3590
• Device Catalogue Number: 3590
• 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: 08/14/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/24/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1