MAUDE Adverse Event Report: VYAIRE MEDICAL INC 17312-00; 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	06/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently, the suspect device has not been returned for evaluation.Therefore, a root cause has not been determined.Currently, patient involvement is unknown.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: screen images disappear and return on the avea ventilator display.Currently, patient involvement is unknown.
Additional Manufacturer Narrative
Device evaluation: g3, g6, h2, h3, h6 & h11.Results of investigation: vyiare medical field service technician went onsite to evaluate the device.Technician replaced user interface module.Ran unit for more then 30 minutes with no issues.Unit passed all performance and safety checks performed.Returned to customer and cleared for clinical use.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: 17312-00
• 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 ; 8478865998
• MDR Report Key: 19701103
• Report Number: 3013421741-2024-00255
• Device Sequence Number: 15383614
• Product Code: CBK
• UDI-Device Identifier: 10190752185784
• UDI-Public: (01)10190752185784
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 09/16/2024
• 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