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

Model Number	AVEA,STD W/CMP,BSC LNG,LO V,DISS, K
Medical Device Problem Codes	Erratic or Intermittent Display (1182); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the screen of the avea ventilator was flickering black and white after replacing the uim (user interface module).There is no information of patient involvement associated with the event as of this time.
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).H3: 81 other - at this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.H3 other text: device was not returned yet.
Additional Manufacturer Narrative
Results of investigation: vyaire medical was able to verify the reported issue.The suspect device was returned for investigation.The reported problem vent screen is flickering black and white failure was duplicated, gde p/n 16650 s/n (b)(6) was installed into gde test station.Powered gde in ventilating mode, gde powered on, uim for a minute was flickering and then it shut off, gde does not power back on.Replaced power driver pcb with plate assembly with a known good power driver pcb with plate assembly.Powered gde in ventilating mode, gde powered on.Performed section 6.10.5 est test which passed.Powered gde in ventilating mode, performed characterize fcv, characterize exv and ovp which also passed.Vyaire was able to duplicate the reported screen flickering black and white failure issue caused by power driver pcb with plate assembly.Driver pcb with plate assembly will be sent to the fa lab for future analysis.

• Brand Name: AVEA VENTILATOR
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618 ; 7607787281
• MDR Report Key: 17233117
• Report Number: 2021710-2023-17853
• Device Sequence Number: 17976383
• Product Code: CBK
• UDI-Device Identifier: 10846446000368
• UDI-Public: (01)10846446000368
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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,STD W/CMP,BSC LNG,LO V,DISS, K
• 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: 05/30/2023
• Supplement Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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