MAUDE Adverse Event Report: VYAIRE MEDICAL INC. FLEXIBLE PATIENT CIRCUIT, 3100A 380-88/400-00 IN HEATED ENVIRONMENT (BOX OF 4); VENTILATOR, HIGH FREQUENCY

Model Number	CKT W/SHRT HTD WIRE 380-88 &400 BX4
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, the suspect device has not been returned for evaluation.No root cause has been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.Device not returned yet.
Event or Problem Description
It was reported to vyaire medical that the 771465 - ckt w/shrt htd wire 380-88 &400 bx4 was becoming disconnected while on the patient.They used tape to secure the circuit.The customer confirmed that there was no patient harm or injury associated with the reported event.

• Brand Name: FLEXIBLE PATIENT CIRCUIT, 3100A 380-88/400-00 IN HEATED ENVIRONMENT (BOX OF 4)
• Common Device Name: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 north riverwoods blvd me; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada vía de la producción; parque undustrial mexicali iii; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16364719
• Report Number: 8030673-2023-00300
• Device Sequence Number: 17845980
• Product Code: LSZ
• UDI-Device Identifier: 50190752155464
• UDI-Public: (01)50190752155464(10)0004190692
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: CKT W/SHRT HTD WIRE 380-88 &400 BX4
• Device Catalogue Number: 771465
• Device Lot Number: 0004190692
• 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: 01/18/2023
• Initial Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/11/2022
• 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: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown