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

Model Number 3100 A

Device Problem Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Event 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.

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)
• Type of Device: 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
• MDR Text Key: 330263579
• Report Number: 2021710-2023-18506
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 50190752159837
• UDI-Public: (01)50190752159837
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 3100 A
• Device Catalogue Number: 29028-012
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1