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

Model Number	17312-00
Medical Device Problem Code	Erratic or Intermittent Display (1182)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique identifier (udi) # - unable to determine entire udi number, as manufacturing information was not provided.Device evaluation update: g3, g6, h3, h6, and h11.Vyaire medical sent a field service representative (fsr) on site to evaluate the avea ventilator.The fse was able to confirm the customer's reported issue.A new user interface module (uim) was installed.A touch screen calibration was conducted.All button functions were tested, verified proper operation, conducted a verification test, and confirmed the unit is operating correctly and ready for clinical use.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
It was reported to vyaire medical: the avea ventilator continues to have a blank screen issue intermittently.No patient involvement.

• Brand Name: AVEA
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC; 26125 north riverwoods blvd; 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 ; 2402760001
• MDR Report Key: 19833309
• Report Number: 3013421741-2024-00302
• Device Sequence Number: 8160167
• Product Code: CBK
• UDI-Device Identifier: 10190752185784
• UDI-Public: (01)10190752185784
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/25/2024

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: 17312-00
• Device Catalogue Number: 17312-00
• 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: 07/10/2024
• Initial Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2010
• 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