MAUDE Adverse Event Report: EVENT MEDICAL EVOLUTION 3E VENTILATOR; CONTINUOUS VENTILATOR

Model Number 3E

Device Problems No Display/Image (1183); Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem Death (1802)

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.".

• Brand Name: EVOLUTION 3E VENTILATOR
• Type of Device: CONTINUOUS 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 Key: 6813505
• MDR Text Key: 83750338
• Report Number: 3006135941-2017-00001
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: GT
• PMA/PMN Number: K113743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Model Number: 3E
• Device Catalogue Number: EVM100500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/25/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 07/25/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death