MAUDE Adverse Event Report: VYAIRE MEDICAL FLEXIBLE PATIENT CIRCUIT, 3100A MR850 IN NON-HEATED ENVIRONMENT (BOX OF 4); VENTILATOR, HIGH FREQUENCY

Model Number BOXED PATIENT CIRCUIT ASSY, 3100A, 850L

Device Problem Disconnection (1171)

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

Event Date 11/28/2023

Event Type  Injury  

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 Description

It was reported to vyaire medical that the boxed patient circuit assy, 3100a, has defective circuit.The circuit separating where tubing joins humidifier and internal wires come out.Loss of pressure ceases hfov (high frequency oscillatory ventilation).Bonding potentially affected in heated circuit.This occurred twice on a particular patient.The customer confirmed that repositioning the circuit system has resolved the issue.The customer confirmed that there was no patient harm associated with the reported event.

• Brand Name: FLEXIBLE PATIENT CIRCUIT, 3100A MR850 IN NON-HEATED ENVIRONMENT (BOX OF 4)
• Type of Device: VENTILATOR, HIGH FREQUENCY
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60004
• Manufacturer (Section G): VYAIRE MEDICAL INC.; 1100 bird center drive; palm springs CA 92262
• Manufacturer Contact: sandra valencia ; 510 technology drive; irvine, CA 92618 ; 8477865998
• MDR Report Key: 18408993
• MDR Text Key: 331490939
• Report Number: 2021710-2023-18574
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 20846446064121
• UDI-Public: (01)20846446064121
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/28/2023

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: BOXED PATIENT CIRCUIT ASSY, 3100A, 850L
• Device Catalogue Number: 29028-004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2023
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Required Intervention