MAUDE Adverse Event Report: VYAIRE MEDICAL FLEXIBLE PATIENT CIRCUIT W/FILTER FOR 3100A (BOX OF 4); VENTILATOR, HIGH FREQUENCY

Model Number	3100 A
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to vyaire medical that the part that sealed the cup outlet was missing from the circuit, preventing it from pressurizing the equipment (air leak) during use on a patient on the 3100 a device.At this time.There is no information regarding patient harm associated with the reported event.
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.

• Brand Name: FLEXIBLE PATIENT CIRCUIT W/FILTER FOR 3100A (BOX OF 4)
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción n; o. 85, parque undustrial mexic; mexicali 21397 ; MX 21397
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 2402760001
• MDR Report Key: 18302727
• Report Number: 2021710-2023-18506
• Device Sequence Number: 6936317
• Product Code: LSZ
• UDI-Device Identifier: 50190752159837
• UDI-Public: (01)50190752159837
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P890057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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: 3100 A
• Device Catalogue Number: 29028-012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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