MAUDE Adverse Event Report: VYAIRE MEDICAL, INC 3100A VENT ASSY,DOMESTIC; VENTILATOR, CONTINUOUS, FACILITY USE

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	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the unit will be pressurized but fails to start.Complainant indicated that there was no patient involvement in the reported malfunction.
Additional Manufacturer Narrative
Some information was not provided and is unknown; therefore, a udi cannot be provided.Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Additional Manufacturer Narrative
The customer did not return the device for evaluation; however, a field service engineer (fse) was able to go onsite to evaluate the device, and upon power-up, the customer reported issue was observed.The root cause could not be determined during the device evaluation.The fse reseated the ddi cable connections and verified the power-on board functionality and performed calibration of the ddi board.All calibration tests passed successfully, and the device was returned to clinical service in normal operating condition.

• Brand Name: 3100A VENT ASSY,DOMESTIC
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• 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: 23227589
• Report Number: 3013421741-2025-01739
• Device Sequence Number: 9686122
• Product Code: LSZ
• UDI-Device Identifier: 10190752155329
• UDI-Public: (01)10190752155329
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/16/2025

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: 09/16/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2025
• Supplement Report FDA Received Date: 11/11/2025
• 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