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

Model Number	770155
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.Udi # was not provided and is unknown at this time.
Event or Problem Description
Complainant reported that the vent does not oscillate.Complainant did not indicate any adverse effect to the patient.
Additional Manufacturer Narrative
A zoll field service engineer (fse) went to the customer site to evaluate the device.During evaluation, the fse was unable to confirm or duplicate the customer's reported issue.The device was run for 1.5 hours with no issues found.Performance check and patient circuit calibration were performed and the unit passed.The vent is operational and meets oem specifications.

• Brand Name: 3100B 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: 23380235
• Report Number: 3013421741-2025-01763
• Device Sequence Number: 9091267
• Product Code: LSZ
• UDI-Device Identifier: 10190752158627
• UDI-Public: (01)10190752158627
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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: 770155
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/24/2025
• Supplement Report FDA Received Date: 12/30/2025
• 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