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

Model Number	768901
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that before use, there was a burning smell when the device was powered on.Complainant indicated that there was no patient involvement in the reported issue.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The device was evaluated by a company field service engineer (fse) who went onsite to investigate the reported of burning smell.Observed that the unit was running loudly and faster than normal.It was recommended to the customer to replace the driver power module.The device also required preventative maintenance (pm).The customer declined pm service that would look into the burning smell.A definitive root cause was unable to be determined due to the declined service.

• 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: 23004672
• Report Number: 3013421741-2025-01691
• Device Sequence Number: 9413146
• Product Code: LSZ
• UDI-Device Identifier: 10190752155329
• UDI-Public: (01)10190752155329
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/20/2025

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 11/24/2025
• 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