MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE MISTY-NEB MEDICATION NEBULIZERS; NEBULIZING SYSTEM, NON-HEATED

Model Number	AIRLIFE MISTY-NEB MEDICATION NEBULIZERS
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No samples were returned as of now.A second nebulizer was obtained and set up.Medication transferred and misted appropriately on the second nebulizer.The customer confirmed that no harm occurred to the patient.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the airlife misty max 10 nebulizer would not mist.The customer confirmed that there was no patient harm associated with this reported event.
Additional Manufacturer Narrative
Result of investigation: review of device history record of the lot number revealed no anomalies, and a sample had been received by the manufacturer for evaluation.Unfortunately, that sample was discarded by mistake.However, technical team indicated that capa-000000567 has been initiated based on a similar problem, and the manufacturing date of the product reported on this complaint is covered by that capa.Therefore, technical team is confirming the reported failure.

• Brand Name: AIRLIFE MISTY-NEB MEDICATION NEBULIZERS
• Common Device Name: NEBULIZING SYSTEM, NON-HEATED
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10001964
• Report Number: 8030673-2020-00095
• Device Sequence Number: 2209061
• Product Code: CAF
• UDI-Device Identifier: 10190752114869
• UDI-Public: (01)10190752114869(10)0004103399
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: AIRLIFE MISTY-NEB MEDICATION NEBULIZERS
• Device Catalogue Number: 002438
• Device Lot Number: 0004103399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2020
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 08/21/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 09/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1