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

Model Number	3100A
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the 3100a unit has issues with a fluctuating frequency.When they try to set the frequency to 14 it will jump to 5 or 6 and fluctuate.The customer confirmed that there is no patient involvement associated with this reported event.
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 : device not returned yet.

• 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: 19393396
• Report Number: 2021710-2024-19103
• Device Sequence Number: 20774010
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20190625
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/24/2024

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
• Device Catalogue Number: 768901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2024
• Initial Report FDA Received Date: 05/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/25/2019
• 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