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

Model Number	A4FX2004
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
There is condensation visible inside the blue plastic filter containing piece of a single use adult anesthesia breathing circuit.The package was not yet open but you can see water droplets/condensation on the blue piece inside of the bag that the circuit came in.

• Brand Name: VITAL SIGNS¿
• Common Device Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATOR)
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 26125 north riverwoods blvd; mettawa IL 60045
• MDR Report Key: 20795823
• Report Number: 20795823
• Device Sequence Number: 15448766
• Product Code: BTM
• UDI-Device Identifier: 10190752119635
• UDI-Public: (01)10190752119635(10)0004286390(11)240606
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/04/2024
• Report Date (Section F): 11/04/2024

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 Model Number: A4FX2004
• Device Catalogue Number: A4FX2004
• Device Lot Number: 0004286390
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 11/04/2024