MAUDE Adverse Event Report: VYAIRE MEDICAL 3100A VENT,115V,60HZ,DOM; VENTILATOR, HIGH FREQUENCY

Model Number	3100A VENT,115V,60HZ,DOM
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text : not returned.
Event or Problem Description
It was reported to vyaire medical that the driver intermittently won't start.Biomed confirmed that it's the start/stop button.The button feels like it doesn't engage correctly like the other buttons.New ddi resolved the issue.No patient involvement reported.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).H3: fse arrived onsite and trouble shot unit.I found the start/stop switch on the ddi board is defective.A 12 k p.M.Was performed in (b)(6) 2024.This is a warranty repair.I replaced the ddi board and performed ddi calibration.The circuit calibration and performance verification passed and unit is ready for use.
Event or Problem Description
Additional information received indicates that a company fse (field service engineer) arrived onsite to troubleshoot the customer issue and was able to resolve the problem.

• Brand Name: 3100A VENT,115V,60HZ,DOM
• 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 ; 2402760001
• MDR Report Key: 19115310
• Report Number: 2021710-2024-19017
• Device Sequence Number: 7140992
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Health Professional
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2024

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: 3100A VENT,115V,60HZ,DOM
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/16/2024
• Supplement Report FDA Received Date: 08/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2017
• 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