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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL INC. AVEA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL INC. AVEA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number AVEA
Medical Device Problem Codes Display or Visual Feedback Problem (1184); Output Problem (3005)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 09/09/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Vyaire medical file identification: (b)(4).At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
 
Event or Problem Description
The customer reported the display going out after a few minutes from power up on the avea ventilator.The customer reported there was no patient involvement associated with the reported event.
 
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Brand Name
AVEA VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL INC.
26125 n. riverwoods blvd.
mettawa IL 60045
MDR Report Key12591363
Report Number2021710-2021-14608
Device Sequence Number17273853
Product Code CBK
UDI-Device Identifier10846446000016
UDI-Public(01)10846446000016
Combination Product (Y/N)N
Initial Reporter StateUT
Initial Reporter CountryUS
PMA/510(K) Number
K103211
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 09/09/2021
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 NumberAVEA
Device Catalogue NumberR17310-00
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/09/2021
Initial Report FDA Received Date10/07/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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