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

Device Problem Disconnection (1171)

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

Event Date 01/16/2023

Event Type  Injury  

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 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)
• Type of Device: 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
• MDR Text Key: 309415752
• Report Number: 8030673-2023-00300
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 50190752155464
• UDI-Public: (01)50190752155464(10)0004190692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 01/18/2023
• Initial Date FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/11/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention