MAUDE Adverse Event Report: VYAIRE MEDICAL BOXED PATIENT CIRCUIT ASSY, 3100A, 850L; VENTILATOR, HIGH FREQUENCY

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

Device Problems Disconnection (1171); Material Too Soft/Flexible (4007)

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

Event Date 12/25/2022

Event Type  malfunction  

Manufacturer Narrative

The customer indicated the actual suspect sample and packaging have been discarded by the nurse after use, but picture was provided that shows disconnection between the tube and the component wye (both used for the manufacture os the suspect sample).Additionally, both the tubing and the component were secured with black cable ties.This confirmed the reported defect.Based on the investigation, environment (temperature/humidity) is related to the reported failure.The tubing part is manufactured with pvc (polyvinyl chloride) resin, and this material tends to lose memory due to degradation during time,pressure and/or temperature.Also due to it's pvc resin material properties, after being assembled and sited on the shelves for long periods of time, the tubing becomes deformed.With the connection being unbonded slip/friction fit and deformation of the tubing, the assembly/connection becomes dislodged by the high frequency oscillation pressures during the application/use.Also, the ifu (instructions for use) indicates that all connections need to be tightened prior use.

Event Description

It was reported to vyaire medical that the boxed patient circuit assy, 3100a, 850l is becoming malleable and loose once heated, allowing the device to get disconnected while being used by a patient.Furthermore, the customer confirmed no harm was done to the patient.

• Brand Name: BOXED PATIENT CIRCUIT ASSY, 3100A, 850L
• 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; no. 85, parque undustrial; mexicali 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology drive; irvine, CA 92618
• MDR Report Key: 16253492
• MDR Text Key: 308921139
• Report Number: 8030673-2023-00294
• Device Sequence Number: 1
• Product Code: LSZ
• UDI-Device Identifier: 50190752159820
• UDI-Public: (01)50190752159820
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P890057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2023

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: BOXED PATIENT CIRCUIT ASSY, 3100A, 850L
• Device Catalogue Number: 29028-011
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1