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

Model Number	768901
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device had a low delta p reading.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.D4: unique identifier (udi) # - unable to determine entire udi# as information was not provided.
Additional Manufacturer Narrative
A zoll medical field service engineer (fse) went to the customer site to evaluate the device.Initial troubleshooting included bypassing the humidifier and installing a new circuit, but delta p remained low at 43 cmh2o.To resolve the issue, the driver displacement indicator board was calibrated to ensure accurate measurement and control.The patient circuit was calibrated and passed, confirming airflow, pressure, and volume delivery were within required parameters.A full ventilation performance check was completed, meeting all operational standards.Verification checks were performed and confirmed that the ventilator is fully operational and compliant with specifications, with map stabilized.The customer was advised to verify power knob alignment and peak-to-peak voltages if further adjustment is required.

• 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 ; 8333273284
• MDR Report Key: 22468200
• Report Number: 3013421741-2025-01629
• Device Sequence Number: 17202119
• Product Code: LSZ
• UDI-Device Identifier: 10190752155329
• UDI-Public: (01)10190752155329
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/23/2025

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: 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: 06/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/10/2025
• Supplement Report FDA Received Date: 08/14/2025
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown