MAUDE Adverse Event Report: VYAIRE MEDICAL AVEA; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number	16465
Medical Device Problem Codes	Failure to Sense (1559); Human-Device Interface Problem (2949)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect component has been returned to vyaire's failure analysis laboratory for evaluation.At this time, the evaluation is still pending.Once the evaluation is complete, a supplemental report will be submitted.
Event or Problem Description
The customer reported a neonatal hotwire flow sensor stopped interfacing with one of their ventilator device, while in patient use.The customer stated no patient impact with this event.
Additional Manufacturer Narrative
The vyaire failure analysis group received the suspect hotwire flow sensors (part number 16465), serial number (b)(4) and (b)(4) for investigation.The fa group performed a visual inspection and found no anomalies.The fa engineer installed the flow sensors into a test device and cycle the device on and duplicated the reported event.The hotwire flow sensors were disassembled for access to the sensor filaments and found liquid fluid contaminated both sensors; found altered filaments on assembly housing.At this time, the reported event was confirmed and duplicated.The, component root cause was caused partially or wholly by the user of the device including sample maintenance handling.

• Brand Name: AVEA
• Common Device Name: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8447938
• Report Number: 2021710-2019-10030
• Device Sequence Number: 10870110
• Product Code: CBK
• UDI-Device Identifier: 10846446001198
• UDI-Public: (01)10846446001198(10)BG0609
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K103211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2019

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: 16465
• Device Catalogue Number: 16465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Received by Manufacturer: 02/28/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 07/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention