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

Lot Number 0004179972

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 06/24/2021

Event Type  malfunction  

Event Description

Manometer on vyaire medical airlife infant manual resuscitator was stuck not allowing the bag to refill properly.Bags removed from service and tested and they appeared to be in working condition during testing over several minutes.

• Brand Name: AIRLIFE¿
• Type of Device: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 n. riverwoods blvd; mettawa IL 60045
• MDR Report Key: 12467023
• MDR Text Key: 271251746
• Report Number: 12467023
• 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: 09/03/2021,09/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0004179972
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2021
• Date Report to Manufacturer: 09/14/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 2