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

Model Number AIRLIFE MISTY-NEB MEDICATION NEBULIZERS

Device Problem Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2020

Event Type  malfunction  

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 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.

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
• Type of Device: NEBULIZING SYSTEM, NON-HEATED
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10001964
• MDR Text Key: 200443600
• Report Number: 8030673-2020-00095
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10190752114869
• UDI-Public: (01)10190752114869(10)0004103399
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 03/30/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 08/21/2020
• Supplement Dates FDA Received: 09/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1