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

Model Number	11790
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Respiratory Distress (2045)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported the suspect filter water trap item#(b)(4) component has not been made available for analysis however, the suspect lot number was provided.At this time, vyaire medical has not received the suspect component for evaluation.In the event that the device is received for evaluation or additional information is received, a follow-up report will be submitted.
Event or Problem Description
The customer reported the breath rate on this ventilator device increased suddenly, while in patient use.The customer observed an open pinch clamp on the filter water trap assembly item#(b)(4), which caused a leak.The customer stated the patient experienced some distress during this event.
Additional Manufacturer Narrative
Vyaire medical received this subject report number (b)(4) request for additional information on july 22, 2019.Vyaire medical responded august 30, 2019 with the additional information regarding this adverse event to the fda.

• 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: 8525232
• Report Number: 2021710-2019-10127
• Device Sequence Number: 14122176
• Product Code: CBK
• UDI-Device Identifier: 20846446001256
• UDI-Public: (01)20846446001256
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K103211
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: 11790
• Device Catalogue Number: 11790
• Device Lot Number: 184098
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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