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 06/10/2021

Event Type  Injury  

Manufacturer Narrative

Vyaire medical was unable to verify the customer's reported issue.The sample device has been discarded and not available for analysis.Additionally, there was no provided photo.Since the lot number of the product involved in the incident could not be provided by the customer, the device history record could not be reviewed and no investigation can be performed and the defect could not be confirmed.Therefore, root cause of failure could not be determined.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

Event Description

The customer reported that the 002002 nebulizer with air entrainment failed to deliver high humidity for the patient with a tracheostomy.The patient experienced thickened secretions / with mucous plug.The product was replaced with the back up device.

• 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
• MDR Report Key: 12139936
• MDR Text Key: 260680655
• Report Number: 8030673-2021-00179
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 10190752144798
• UDI-Public: (01)10190752144798
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial
• Report Date: 06/14/2021

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: NEBULIZER WITH AIR ENTRAINMENT
• Device Catalogue Number: 002002
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/14/2021
• Initial Date FDA Received: 07/08/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention