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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL AVEA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL AVEA VENTILATOR; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number AVEA
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Information (3190)
Date of Event 02/19/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Investigation results revealed that both of the fuses on the power input are busted.After replacement of the fuse, the fuse gets blown even before the unit is switched on so power supply was evaluated and it was determined that there was a damaged component on the power supply.The power pcb was replaced.
 
Event or Problem Description
The customer reported that they heard something pop on the avea std comp device and the device blacks out while being used on a patient.The customer switched off and on the unit but it is not powering on.As of this time, there is no information about patient harm in this reported event.
 
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Brand Name
AVEA VENTILATOR
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
MDR Report Key9870586
Report Number2021710-2020-11661
Device Sequence Number10902891
Product Code CBK
UDI-Device Identifier10846446000351
UDI-Public(01)10846446000351(11)20180824
Combination Product (Y/N)N
Initial Reporter CountryRP
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 02/21/2020
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 STD W/COMP
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/21/2020
Initial Report FDA Received Date03/23/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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