MAUDE Adverse Event Report: VYAIRE MEDICAL AIRLIFE® HIGH FLOW FIO2 NEBULIZER; NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)

Model Number	AIRLIFE® HIGH FLOW FIO2 NEBULIZER
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the product sample and photo is available for analysis.At this time, vyaire has not received the suspect device for evaluation.Any additional information provided by the customer will be included in a follow-up report.
Event or Problem Description
The customer reported that the airlife high flow fio2 nebulizer's threaded connection fell off and disconnected from the wall.The event occurred while connected to a patient.The customer reported that they had replaced the adapter and placed the patient on a non-re-breathing oxygen mask and confirmed that no patient harm was associated on this event.
Additional Manufacturer Narrative
Device evaluation: d4, d10, g4, h2, h3, h4, h6 and h10.Result of investigation:vyaire medical conducted a failure investigation, the device history record (dhr) review show no deviations to manufacturer specification.One opened sample of the p/n 441h without lot number.A visual inspection per pqas 441g etal was performed and found that the sample does not have the component p/n 070-90080 (wing nut, misty ox).Based on the investigation, it is determined that the personnel are related with defect reported, since they should assembly manually the component p/n 070-90080.

• Brand Name: AIRLIFE® HIGH FLOW FIO2 NEBULIZER
• Common Device Name: NEBULIZER, MEDICINAL, NON-VENTILATORY (ATOMIZER)
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 9593752
• Report Number: 8030673-2020-00069
• Device Sequence Number: 2696568
• Product Code: CCQ
• UDI-Device Identifier: 10190752131910
• UDI-Public: (01)10190752131910(10)0004105414
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AIRLIFE® HIGH FLOW FIO2 NEBULIZER
• Device Catalogue Number: M37441H
• Device Lot Number: 0004105414
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention