MAUDE Adverse Event Report: VYAIRE MEDICAL INC 3100A VENT; VENTILATOR, HIGH FREQUENCY

Model Number	768901
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the 3100a vent stopped oscillating while on patient.The unit was swapped out to complete the procedure.No patient harm reported.
Additional Manufacturer Narrative
File identification: (b)(4).Results of investigation: a non-return device evaluation was performed it was confirmed that the unit was tested, and the reported issue was not confirmed.A supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: 3100A VENT
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettewa IL 60045
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 21251477
• Report Number: 3013421741-2025-00591
• Device Sequence Number: 9116858
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20231115
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 768901
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown