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

Model Number	770155
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacture date is unknown, zoll medical corporation has not received the device for evaluation, and this complaint is still under investigation.
Event or Problem Description
It was reported that while treating a patient, the device's map dropped.Adverse effect to the patient was not indicated.
Additional Manufacturer Narrative
The customer did not return the defective device for evaluation, but a field service engineer (fse) was able to go onsite to evaluate the device.The fse found that the device had a used patient circuit still attached which showed a clear disconnection.A disconnected circuit is a known cause of sudden map loss; however, due to the circuit being contaminated, the fse could not test the unit using the customer's setup.Instead they installed a known good circuit onto the device and proceeded with their evaluation and testing.The fse performed a full performance check and a circuit calibration, and all tests passed without any issues.The unit was run for an extended period, and no map drop or related abnormal behavior could be reproduced.No fault was found with the device.The device is operating as intended and is cleared for clinical use.

• 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: 23291109
• Report Number: 3013421741-2025-01744
• Device Sequence Number: 14668497
• Product Code: LSZ
• UDI-Device Identifier: 10190752158627
• UDI-Public: (01)10190752158627
• 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): 09/23/2025

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
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/25/2025
• 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