MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE MISTY FINITY DIRECT CONNECT LARGE VOLUME CONTINUOUS NEBULIZER; NEBULIZER (DIRECT PATIENT INTERFACE)

Model Number	AIRLIFE MISTY FINITY DIRECT CONNECT LARGE VOLUME CONTINUOUS NEBULIZER
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).At this time, vyaire has not received the suspect device for evaluation.Any additional information received from the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the tube of airlife misty finity continuous nebulizers is too short to deliver medicine to the patient.At this time, patient involvement is unknown.
Additional Manufacturer Narrative
Additional information: the customer reported that there is no patient harm associated in this event.Result of investigation: vyaire failure analysis laboratory performed analysis on device history record, and it was noticed in subassy dhr that an non conforming material report was issued due to dimensional anomalies it was also noticed that a previous version of the pqas involved had the wrong length specified; this issue was corrected and a new version of the document was issued in october 16, 2019 now showing the correct length.It is probable that some material out of specification was not sorted out and used in assembly.

• Brand Name: AIRLIFE MISTY FINITY DIRECT CONNECT LARGE VOLUME CONTINUOUS NEBULIZER
• Common Device Name: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9639888
• Report Number: 8030673-2020-00071
• Device Sequence Number: 16833531
• Product Code: CAF
• UDI-Device Identifier: 10885403039249
• UDI-Public: (01)10885403039249(10)0004115366
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

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 FINITY DIRECT CONNECT LARGE VOLUME CONTINUOUS NEBULIZER
• Device Catalogue Number: 002502
• Device Lot Number: 0004115366
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 01/28/2020
• Supplement Report FDA Received Date: 03/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1