MAUDE Adverse Event Report: VYAIRE MEDICAL 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV); VENTILATOR, HIGH FREQUENCY

Model Number	3100 B
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H10: vyaire field service went onsite replace3 ohms driver.Cannot zero mean pressure order alarm pcb (printed circuit board).
Event or Problem Description
It was reported to vyaire medical that the 3100b when device is powered on, the map incrementally increased to max (~60cmh2o) without any intervention.The customer confirmed that there is no patient involvement associated with this reported event.
Additional Manufacturer Narrative
Updated information:g3, g6, h2 and h10 additional information:as a resolution, replace pressure transducer pwb assembly.All work accomplished per 3100b service manual.Performed patient circuit calibration and performance check, unit passes.Vent is operational and meets oem (original equipment manufacture) specifications.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h6 and h11 result of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The reported ¿map incrementally increased to max¿ was not duplicated, however a voltage fluctuation at ambient pressure was found during testing which caused zero calibration reading on test vent to drift outside of the ±0.3cmh2o spec when compared to actual reading from external manometer.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR (HFOV)
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 18622970
• Report Number: 2021710-2024-18720
• Device Sequence Number: 15330731
• Product Code: LSZ
• UDI-Device Identifier: 10846446003543
• UDI-Public: (01)10846446003543
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2024

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: Health Professional
• Device Model Number: 3100 B
• Device Catalogue Number: 770155
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2023
• Supplement Date Received by Manufacturer: 03/22/2024; 02/19/2025
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 04/15/2024; 02/20/2025
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown