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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 Mechanical Problem (1384)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 04/21/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(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's blender is giving wrong data which is out of specification.The customer confirmed that there was no patient involvement associated with the reported event.
 
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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 Key10070640
Report Number2021710-2020-12015
Device Sequence Number5413922
Product Code CBK
UDI-Device Identifier10846446015966
UDI-Public(01)10846446015966(11)20100107
Combination Product (Y/N)N
Initial Reporter CountryCS
PMA/510(K) Number
K103211
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/21/2020
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 COMP
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/21/2020
Initial Report FDA Received Date05/19/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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