MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. VITAL SIGNS; VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)

Model Number 5102RVW

Device Problems Increase in Pressure (1491); Structural Problem (2506)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 09/12/2021

Event Type  Injury  

Event Description

We had a serious safety event in our pediatric icu that involved the use of a flow-inflating manual resuscitator bag.The pressure release valve was left closed while giving breaths, causing high pressures to enter the lungs which resulted in injury to the patient.Manufacturer response for breathing circuit, jackson rees breathing circuit (per site reporter): alerted the manufacturer, provided the medsun report number and the details of the event that they requested.

• Brand Name: VITAL SIGNS
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 1100 bird center drive; palm springs CA 92262
• MDR Report Key: 12646685
• MDR Text Key: 276852076
• Report Number: 12646685
• Device Sequence Number: 1
• Product Code: BTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 5102RVW
• Device Catalogue Number: 5102RVW
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention