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

Model Number	768901
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that there is a loud leaking noise coming from the driver compartment.There was no patient involvement reported.
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).81 other - at this time, the suspect device has not been returned for evaluation.There was no patient involvement reported.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.

• Brand Name: 3100A HFOV
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL INC; 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: 19558819
• Report Number: 3013421741-2024-00200
• Device Sequence Number: 6711750
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)19980428
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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: 768901
• Device Catalogue Number: 768901
• Device Lot Number: N/A
• 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: 05/22/2024
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/28/1998
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown