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

Model Number	3100A VENT,115V,60HZ,DOM
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).It was determined by vyaire technical support the settings on 3100a would cause centering probe to overheat and become less stable.The settings used (per photo provided by the customer) are more appropriate on 3100 as device is setup to manage that level of generated heat.No patient involvement was reported.Technical support inquired if they still want the device checked out.Onsite fst (field service technician) visit will be scheduled.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical the 3100a ventilator needs an fst (field service technician) to evaluate.There was concern of the piston not centering while at the settings they needed, but switched the unit with a 3100b and the settings were fine.
Additional Manufacturer Narrative
Results of investigation: vyaire medical field service technician went onsite to evaluate the device.Technician adjusted dynamic displacement indicator and pr3.Ran patient circuit check.Ran performance check.All tests passed required criteria.Unit meets factory specifications.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: 3100 HIGH FREQUENCY OSCILLATING VENTILATOR
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 north 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 ; 8478865998
• MDR Report Key: 19322879
• Report Number: 2021710-2024-19084
• Device Sequence Number: 15036743
• Product Code: LSZ
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 05/15/2024

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: 04/16/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/1998
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown