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

Model Number	768901
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while attempting to treat a patient (age & gender unknown), the device's piston wouldn't start and failed to cycle/oscillate.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The ventilator piston will not engage until the system reaches at least 20% of the high alarm limit.In this case, the high alarm limit was set to 49 cmh2o, requiring approximately 9.810 cmh2o to initiate piston movement, matching the behavior reported by rt staff.Adjusting the high alarm limit to a lower value would reduce the required starting pressure, allowing the piston to engage as expected.The condition was attributed to the configured high alarm limit and not a device malfunction.

• Brand Name: 3100A HFOV
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL, INC; 26125 n. riverwoods blvd; mettawa IL 60045
• Manufacturer Contact: mindy faber ; 1100 bird center dr.; palm springs, CA 92262 ; 8333273284
• MDR Report Key: 22893847
• Report Number: 3013421741-2025-01677
• Device Sequence Number: 5828282
• Product Code: LSZ
• UDI-Device Identifier: 10190752155329
• UDI-Public: (01)10190752155329
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2025

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
• Operator of Device: Other
• Device Model Number: 768901
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown