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

Catalog Number	16532-00
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire medical 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.
Event or Problem Description
It was reported to vyaire medical that the vent went inop.While transporting patient within hospital.They were able to bag the patient so no harm.
Event or Problem Description
Additional information received indicating that a vyaire medical fse was able to go to customer site and troubleshoot the issue.All tests passed required criteria.Unit meets factory specs.
Additional Manufacturer Narrative
Vyaire medical file identification: com (b)(4).H3: fse arrived on site to troubleshoot.Confirmed vent inop error in event log.Alarm came after repeated circuit disconnect alarms.Examined exhalation valve setup & flow sensor.Noticed receptacle was loose to the ex valve.Secured loose screws.Reconnected circuit.No alarms present at startup.Fio2 monitoring is disabled.O2 inlet low (40-43psi).Booted in service mode.Ran leak test.Passed.Ran fio2 monitoring cal.Passed.Rebooted.Ran ovp.All tests passed required criteria.Unit meets factory specs.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: VELA
• 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: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 19472044
• Report Number: 3013421741-2024-00156
• Device Sequence Number: 12636985
• Product Code: CBK
• UDI-Device Identifier: 10190752153325
• UDI-Public: (01)10190752153325(11)20070425
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093094
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/17/2024

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: 16532-00
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/05/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2007
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown