MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE MISTY-NEB MEDICATION NEBULIZERS; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number IRLIFE MISTY-NEB MEDICATION NEBULIZERS

Device Problem Defective Component (2292)

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

Event Date 12/04/2020

Event Type  malfunction  

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.

Event Description

The customer reported that the blue center piece of the airlife misty-neb medication nebulizers has been flying off.It is also reported that medication time has been going through in 12 minutes.However, there has been no injury or harm associated with the event.

Manufacturer Narrative

Device evaluation: g3, g6, h2, h3, h6 and h10.Since no sample or picture were provided for the investigation, the defect reported by the customer was not confirmed.The device history record (dhr) review did not show any deviations to manufacturer specifications.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.

• Brand Name: AIRLIFE MISTY-NEB MEDICATION NEBULIZERS
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11097809
• MDR Text Key: 239486232
• Report Number: 8030673-2020-00139
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10190752114821
• UDI-Public: (01)10190752114821(10)0004131504
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IRLIFE MISTY-NEB MEDICATION NEBULIZERS
• Device Catalogue Number: 002433
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1