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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EVENT MEDICAL EVOLUTION 3E VENTILATOR; CONTINUOUS VENTILATOR
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EVENT MEDICAL EVOLUTION 3E VENTILATOR; CONTINUOUS VENTILATOR Back to Search Results
Model Number 3E
Health Effect - Clinical Code Death (1802)
Date of Event 07/25/2018
Type of Reportable Event Death
Additional Manufacturer Narrative
The product is not distributed in the usa.
 
Event or Problem Description
A distributor reported that a clinical manager of the hospital where service is provided: at about 3 am the vent started to emit an alarm and instantly got black screen, and the vent displayed a message on screen "vent inop and icon on screen" and the vent stopped running and shut down and continued giving an alarm.
 
Additional Manufacturer Narrative
We had an original report of a death from our distributor in (b)(4).It did not contain complete information such as date of death.We requested additional information.We received this further information late yesterday from the distributor stating, "please disregard the information about a dead patient.The patient was not connected to any event ventilator.".
 
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Brand Name
EVOLUTION 3E VENTILATOR
Common Device Name
CONTINUOUS VENTILATOR
Manufacturer (Section D)
EVENT MEDICAL
60 empire dr
lake forest CA 92630
MDR Report Key6813505
Report Number3006135941-2017-00001
Device Sequence Number1171339
Product Code CBK
Combination Product (Y/N)N
Initial Reporter CountryGT
PMA/510(K) Number
K113743
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign
Initial Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date (Section B) 07/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Other
Device Model Number3E
Device Catalogue NumberEVM100500
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/25/2017
Supplement Date Received by Manufacturer07/25/2017
Initial Report FDA Received Date08/23/2017
Supplement Report FDA Received Date08/24/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
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