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

Model Number	3100A VENT,115V,60HZ,DOM
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to vyaire medical that rts reported the map was reading 129cmh2o while on patient and that vent would not shut off.Rts indicated that vent passed pre-use checks.
Additional Manufacturer Narrative
Vyaire medical file indentification: (b)(4).H3: 81 other ¿ currently, the suspect device has not been returned for evaluation.Therefore, a root cause has not been determined.No patient involvement.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Additional Manufacturer Narrative
Results of investigation: vyaire medical field service technician went onsite to evaluate the device.Technician bypassed blender.Used circuit already installed on vent & humidifier to test.Powered up unit.At patient circuit check vent is reading 42.1 map.At performance check settings vent is reading 23.4 map & 62 deltap.Both in specification.Dynamic displacement indicator calibration slightly off.Calibrated.Reran patient circuit check & performance check.Both passed.Allowed unit to ventilate w driver running at performance check settings.No alarms present.Unable to replicate high map issue reported.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 (HFOV)
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 1100 bird center drive; 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: 19255587
• Report Number: 3010838917-2024-00119
• Device Sequence Number: 20432355
• Product Code: CBK
• UDI-Device Identifier: 10846446003079
• UDI-Public: (01)10846446003079(11)20191021
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 10/31/2024
• Initial Report FDA Received Date: 05/06/2024
• Supplement Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2019
• 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