MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE FILTERED SMALL VOLUME NEBULIZER SYSTEM; NEBULIZER (SMALL VOLUME)

Model Number	AIRLIFE
Medical Device Problem Code	Chemical Problem (2893)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/19/2020
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 was received.
Event or Problem Description
The customer reported that the 124030eu airlife® filtered small volume nebulizer system experienced much longer therapy (nebulizing pentamidine) than they used to be.Filter lets through medication which are irritating for clinician.Also "white smoke" which came out of the filter that irritated their eyes after treatment.The customer confirmed that there was no harm or hazard occurred to the patient.They still continued even though it looked longer and even there was emanations in the room.No intervention was done to the patient.
Additional Manufacturer Narrative
Result of investigation: the vyaire failure analysis laboratory received the two open samples from p/n 124030eu without lot number for the investigation.A visual inspection was performed and no issues were found the two samples.Therefore, reported defect was not confirmed.The root cause is cannot be confirmed.

• Brand Name: AIRLIFE FILTERED SMALL VOLUME NEBULIZER SYSTEM
• Common Device Name: NEBULIZER (SMALL VOLUME)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10498067
• Report Number: 8030673-2020-00118
• Device Sequence Number: 2889880
• Product Code: CAF
• UDI-Device Identifier: 10190752144828
• UDI-Public: (01)10190752144828(10)0004121112
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K874395
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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
• Device Catalogue Number: 124030EU
• Device Lot Number: 0004121112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2020
• Initial Date Received by Manufacturer: 08/19/2020
• Supplement Date Received by Manufacturer: 09/22/2020
• Initial Report FDA Received Date: 09/05/2020
• Supplement Report FDA Received Date: 10/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1