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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device computer-assisted personalized sedation system
Definition Computer assisted system to administer a drug and control depth of sedation and provide monitoring and alarms for physiological vital signs and other parameters of sedation.
Product CodePDR
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 1 3 5 3 0 0 0 0 0 0 0 0

MDR Year MDR Reports MDR Events
2014 3 3
2015 8 8
2016 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Improper or Incorrect Procedure or Method 3 3
Device Operates Differently Than Expected 2 2
Difficult to Open or Close 1 1
Mechanics Altered 1 1
Insufficient Information 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Other (for use when an appropriate patient code cannot be identified) 6 6
No Consequences Or Impact To Patient 5 5
Muscle Spasm(s) 1 1
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ethicon Endo-Surgery Inc I Aug-26-2015
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