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

Catalog Number	17310-00
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical: the unit was being set up for a demo.Delivered and monitored issues.No analyzer comparison.He can't get his analyzer to analyze such small volumes.No patient involved.
Additional Manufacturer Narrative
Vyaire medical investigation file # com (b)(4).81 other ¿ currently, the suspect device has not been returned for evaluation.Therefore, a root cause has not been determined.No patient involvement.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AVEA
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL INC
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 26125 north riverwoods blvd; mettawa, CA 60045 ; 8478865998
• MDR Report Key: 19537007
• Report Number: 3013421741-2024-00182
• Device Sequence Number: 17748698
• Product Code: CBK
• UDI-Device Identifier: 10190752185777
• UDI-Public: (01)10190752185777(11)20080214
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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 Catalogue Number: 17310-00
• 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: 05/22/2024
• Initial Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2008
• 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