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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
Event Date 07/25/2018
Event Type  Death  
Manufacturer Narrative

The product is not distributed in the usa.

 
Event 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.

 
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 NameEVOLUTION 3E VENTILATOR
Type of DeviceCONTINUOUS VENTILATOR
Manufacturer (Section D)
EVENT MEDICAL
60 empire dr
lake forest CA 92630
Manufacturer Contact
faye dunn
60 empire dr
lake forest , CA 92630
9499001917
MDR Report Key6813505
Report Number3006135941-2017-00001
Device Sequence Number1
Product CodeCBK
Report Source Manufacturer
Reporter Occupation BIOMEDICAL ENGINEER
Report Date 07/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator OTHER
Device MODEL Number3E
Device Catalogue NumberEVM100500
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/25/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/12/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/23/2017 Patient Sequence Number: 1
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