MAUDE Adverse Event Report: VYAIRE MEDICAL INC. 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	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A vyaire field service representative(fsr) evaluated the device onsite and verfied the reported complaint.Found that the monitored vte (end-tidal volume) was inaccurate.Tried calibration on exp press and flow and the calibration passed.However, the problem persisted.The leakage percentage value is also higher than normal.The circuit and exp corner were checked for leaks but there was none found.The exp flow sensor and exhalation diaphragm were replaced but there was no change.The unit needs a new exp flow pcb (printed circuit board).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 not adequate tidal volumes on a patient on the avea ventilator.The customer reported the patient was moved to another ventilator.At this time, there is no information regarding patient harm associated with the reported event.

• Brand Name: AVEA VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 12129822
• Report Number: 2021710-2021-14082
• Device Sequence Number: 14558996
• Product Code: CBK
• UDI-Device Identifier: 10846446000016
• UDI-Public: (01)10846446000016(11)20100423
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2021

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: AVEA
• Device Catalogue Number: R17310-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention