MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AIRLIFE¿ VOLUME VENTILATOR CIRCUIT 1.6 M (5'); SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)

Model Number	CIRCUIT VENT VOL F/PORT 10/CS
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 001795 circuit vent vol f/port 10/cs is faulty during patient use.The customer confirmed no harm was done to the patient.
Additional Manufacturer Narrative
Additional information: g3, g6, h2, h3, h6 and h10 result of investigation: vyaire medical was unable to confirm the reported issue.Based on the investigation and per pictures sent by the customer and since no lot number or physical sample of fg 001795-a was provided we cannot confirm the reported defect since we require the physical sample to perform a better investigation, without the physical sample we are unable to perform tests on the reported device and stablish a root cause.Customer reported that the fg part number 001795-a has a "faulty item" without any other detail of the failure.However, in the picture sent by the customer is not possible for us to clearly see any issue in the fg 001795-a or the component 65-1427.Additionally, we checked for any issues with the manufacturing of fg 001795-a over the last 3 years and no ncmr's were found related with the reported defect.

• Brand Name: AIRLIFE¿ VOLUME VENTILATOR CIRCUIT 1.6 M (5')
• Common Device Name: SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS)
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18209890
• Report Number: 8030673-2023-00359
• Device Sequence Number: 20436679
• Product Code: BZO
• UDI-Device Identifier: 10190752144729
• UDI-Public: (01)10190752144729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2023

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: CIRCUIT VENT VOL F/PORT 10/CS
• Device Catalogue Number: 1795
• Device Lot Number: UNKNOWN
• 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: 11/02/2023
• Supplement Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 02/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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