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

Device Problem Component Incompatible (1108)

Patient Problem No Information (3190)

Event Date 12/09/2019

Event Type  malfunction  

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 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.

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
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9639888
• MDR Text Key: 199989912
• Report Number: 8030673-2020-00071
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 10885403039249
• UDI-Public: (01)10885403039249(10)0004115366
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1