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

Model Number	768901
Medical Device Problem Codes	Mechanical Problem (1384); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
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.D4.Udi# - the device was manufactured in 2014 and was not subject to udi requirements.
Event or Problem Description
Complainant alleged that while attempting to treat a patient (age & gender unknown), the device stopped running.Complainant did not indicate that there was any adverse effect to the patient due to the reported malfunction.
Additional Manufacturer Narrative
Updated sections: g6, h2, h6, and h11.A field service engineer went onsite to evaluate the device.Upon evaluation, it was found that the reported issue could not be replicated during testing.The unit functioned without any alarms, and all measurements fell within acceptable limits.During the inspection of the airway sense line, it was discovered that the pr6 pressure regulator exhibited fluctuating output values when the setscrew was touched.This instability may be the probable cause of the internal failure.Inconsistent pressure from the regulator likely triggered a fault, causing the driver to shut down.No other faults or failures were identified during the evaluation.However, due to the unstable readings from the pr6 regulator, replacement was recommended.

• Brand Name: 3100A HFOV
• 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 ; 8333273284
• MDR Report Key: 21921070
• Report Number: 3013421741-2025-01547
• Device Sequence Number: 8743224
• Product Code: LSZ
• UDI-Device Identifier: 10190752155329
• UDI-Public: (01)10190752155329
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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: 04/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2014
• 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