MAUDE Adverse Event Report: VYAIRE MEDICAL AVEA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	AVEA
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).Vyaire medical field service went onsite.Ventilator hours is 33645 equipment number 50389746.The ventilator was out of service for several months.Found that the unit is without o2 (oxygen) sensor and internal battery.As a resolution installed new o2 (oxygen) sensor and internal battery.Verified that the monitored and delivered fio2 (fraction of inspired oxygen) were not agreeing with the set fio2 (fraction of inspired oxygen).Also found that the monitored vte (end tidal volume) was reading very low when compared to set vte (end tidal volume) and delivered vte (end tidal volume).Ran the expiratory flow, expiratory pressure and air - o2 regulator differential balance calibration procedures.After calibrations the fio2 and the vte (end tidal volume are now correct.Ran ovp (operators verification procedure) the ventilator is functioning properly.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported to vyaire medical that the avea ventilator has fio2 (fraction of inspired oxygen) blender issue.As of this time, there is no information about patient involvement associated in this reported event.

• Brand Name: AVEA VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 12849155
• Report Number: 2021710-2021-14976
• Device Sequence Number: 4547031
• Product Code: CBK
• UDI-Device Identifier: 10846446000368
• UDI-Public: (01)10846446000368(11)20050203
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K103211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/22/2021

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: AVEA
• Device Catalogue Number: 17312-00
• 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: 10/22/2021
• Initial Report FDA Received Date: 11/19/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2005
• 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