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

Model Number AIRLIFE

Device Problem Chemical Problem (2893)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/19/2020

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 was received.

Event 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.

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
• Type of Device: NEBULIZER (SMALL VOLUME)
• Manufacturer (Section D): VYAIRE MEDICAL; 26125 n. riverwoods blvd.; mettawa, il
• MDR Report Key: 10498067
• MDR Text Key: 206394255
• Report Number: 8030673-2020-00118
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10190752144828
• UDI-Public: (01)10190752144828(10)0004121112
• Combination Product (y/n): N
• PMA/PMN Number: K874395
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1