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

Model Number	768901
Medical Device Problem Code	Failure to Cycle (1142)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the product for evaluation and this complaint is still under investigation.H4: device manufacture date is unknown.
Event or Problem Description
It was reported that the driver on the device stopped working twice while being used on a patient.Another device was used.Complainant indicated that there was no adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
The device was evaluated by a company field service engineer (fse) that was dispatched to the customer site.A full performance check and power supply check was conducted.The pneumatics and driver controller board were also inspected during evaluation.The fse allowed the device to run for over an hour and was unable to confirm or duplicate the reported malfunction.All performance tests and calibrations passed without any issues.

• 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
• MDR Report Key: 23210006
• Report Number: 3013421741-2025-01733
• Device Sequence Number: 18574294
• Product Code: LSZ
• UDI-Device Identifier: 10190752155329
• UDI-Public: (01)10190752155329
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): Unknown
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2025

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 10/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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