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

Model Number	AVEA
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire field service representative (fsr) went onsite and evaluated the ventilator.Upon checking, fsr noticed constant circuit disconnected.Troubleshooting was performed; however, the error is still there.Fsr determined a new gas delivery engine (gde) is needed.Part was sent to customer.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 that the avea showed 87% leak during ventilation on a patient.The device was removed from the patient and they replaced another device.At this time, patient harm is unknown.
Additional Manufacturer Narrative
Result of investigation: the vyaire failure analysis laboratory received the suspect component and performed a failure investigation.The reported complaint was unable to be confirmed or duplicated.As a precautionary measure, the tca assembly with new tca board assembly will be replaced.Factory service department to install a new pcba, patient assist call and tca then have assembly processed.

• Brand Name: AVEA VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL.; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 9806888
• Report Number: 2021710-2020-11483
• Device Sequence Number: 778751
• Product Code: CBK
• UDI-Device Identifier: 10846446000351
• UDI-Public: (01)10846446000351(11)20050629
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K103211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2020

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: 17212-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 06/04/2020
• Initial Report FDA Received Date: 03/09/2020
• Supplement Report FDA Received Date: 07/27/2020
• 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