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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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Device
cart, emergency, cardiopulmonary (excluding equipment)
Product Code
BZN
Regulation Number
868.6175
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
3
3
2019
8
8
2020
4
4
2021
8
8
2022
29
29
2023
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
14
14
No Display/Image
10
10
Output Problem
8
8
Unintended Movement
8
8
Loss of Power
7
7
Thermal Decomposition of Device
7
7
Intermittent Energy Output
5
5
Overheating of Device
4
4
Ambient Temperature Problem
4
4
Material Discolored
4
4
Positioning Problem
3
3
Therapeutic or Diagnostic Output Failure
2
2
Material Integrity Problem
2
2
Device Fell
2
2
Energy Output Problem
2
2
Device Slipped
2
2
Unstable
1
1
Arcing
1
1
Sparking
1
1
Break
1
1
Display or Visual Feedback Problem
1
1
Fracture
1
1
Loose or Intermittent Connection
1
1
Melted
1
1
Misassembled
1
1
Nonstandard Device
1
1
Unintended System Motion
1
1
Intermittent Loss of Power
1
1
Material Twisted/Bent
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Electrical Shorting
1
1
Failure to Power Up
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
43
43
Insufficient Information
12
12
No Known Impact Or Consequence To Patient
11
11
No Information
2
2
Laceration(s)
1
1
No Consequences Or Impact To Patient
1
1
Superficial (First Degree) Burn
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Corporation
II
Mar-05-2020
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