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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL ENFLOW CONTROLLER UNIT
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VYAIRE MEDICAL ENFLOW CONTROLLER UNIT Back to Search Results
Model Number 980121EU
Medical Device Problem Code Device Emits Odor (1425)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 11/08/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, vyaire has not received the sample for investigation.
 
Event or Problem Description
Customer reported the enflow controller unit exploded with a burning smell.The issue occurred on set up prior to patient-use.The customer reported there is no patient involvement associated with the event.
 
Additional Manufacturer Narrative
Device evaluation: d10, g4, h3, h6, and h10.Results of investigation: the suspect component was returned for evaluation.Based on the evaluation the reported defect could not be traced or reproduced.
 
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Brand Name
ENFLOW CONTROLLER UNIT
Common Device Name
ENFLOW CONTROLLER UNIT
Manufacturer (Section D)
VYAIRE MEDICAL
26125 north riverwoods blvd
mettawa IL 60045
MDR Report Key8129188
Report Number3008959444-2018-00003
Device Sequence Number294981
Product Code LGZ
UDI-Device Identifier10885403296819
UDI-Public(01)10885403296819
Combination Product (Y/N)N
Initial Reporter CountryUK
PMA/510(K) Number
K130867
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source foreign,health professional,u
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 11/13/2018
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 Number980121EU
Device Catalogue Number980121EU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2018
Initial Date Received by Manufacturer 11/12/2018
Supplement Date Received by Manufacturer04/09/2019
Initial Report FDA Received Date12/04/2018
Supplement Report FDA Received Date04/11/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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