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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL AVEA VENTILATOR; VENTILATOR, HIGH FREQUENCY
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VYAIRE MEDICAL AVEA VENTILATOR; VENTILATOR, HIGH FREQUENCY Back to Search Results
Model Number AVEA
Medical Device Problem Code Infusion or Flow Problem (2964)
Health Effect - Clinical Code No Information (3190)
Date of Event 04/03/2020
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 that the avea ventilator has no o2 flow and fio2 inaccuracy.There is no information regarding patient involvement.
 
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Brand Name
AVEA VENTILATOR
Common Device Name
VENTILATOR, HIGH FREQUENCY
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
MDR Report Key10012370
Report Number2021710-2020-11890
Device Sequence Number11284906
Product Code CBK
UDI-Device Identifier10846446000351
UDI-Public(01)10846446000351(11)20080319
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K103211
Number of Events Summarized1
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
Report Date (Section B) 04/03/2020
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 NumberAVEA STD COMP
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/03/2020
Initial Report FDA Received Date04/29/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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