MAUDE Adverse Event Report: VYAIRE MEDICAL INC. NEBULIZER WITH AIR ENTRAINMENT; HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE

Model Number NEBULIZER WITH AIR ENTRAINMENT

Device Problem Moisture or Humidity Problem (2986)

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

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

Vyaire medical file identification: (b)(4).The customer confirmed that the sample is not available for return.Therefore, no root cause could be determined.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 002002 - nebulizer with air entrainment does not humidify the air despite being replaced and securing the connection.The humidified air is needed for a patient with tracheostomy.There were no reports of injury/harm.

• Brand Name: NEBULIZER WITH AIR ENTRAINMENT
• Type of Device: HUMIDIFIER, RESPIRATORY GAS, (DIRECT PATIENT INTERFACE
• Manufacturer (Section D): VYAIRE MEDICAL INC.; 26125 n. riverwoods blvd.; mettawa IL 60045
• Manufacturer (Section G): PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V.; cerrada via de la produccion; no. 85, parque undustrial mex; mexicali, 21397 ; MX 21397
• Manufacturer Contact: erika bonilla ; 510 technology dr; irvine, IL 92618 ; 7149227837
• MDR Report Key: 15189074
• MDR Text Key: 304891700
• Report Number: 8030673-2022-00265
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10885403006425
• UDI-Public: (01)10885403006425
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2022

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: NEBULIZER WITH AIR ENTRAINMENT
• Device Catalogue Number: 2002
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2022
• Initial Date FDA Received: 08/08/2022
• Was Device Evaluated by Manufacturer?: No
• 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