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

Model Number	IRLIFE MISTY-NEB MEDICATION NEBULIZERS
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa IL 60045
• MDR Report Key: 11097809
• Report Number: 8030673-2020-00139
• Device Sequence Number: 14463518
• Product Code: CAF
• UDI-Device Identifier: 10190752114821
• UDI-Public: (01)10190752114821(10)0004131504
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

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
• Operator of Device: Health Professional
• Device Model Number: IRLIFE MISTY-NEB MEDICATION NEBULIZERS
• Device Catalogue Number: 002433
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/04/2020
• Supplement Date Received by Manufacturer: 01/08/2021
• Initial Report FDA Received Date: 12/30/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1