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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
centrifuge, hematocrit
Product Code
GKG
Regulation Number
864.6400
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
15
15
2015
3
3
2019
4
4
2020
1
1
2021
1
1
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Inoperable
12
12
Thermal Decomposition of Device
5
5
Fracture
4
4
Smoking
3
3
Device Operates Differently Than Expected
3
3
Melted
3
3
Leak/Splash
2
2
Material Fragmentation
2
2
Detachment Of Device Component
2
2
Sparking
1
1
Charred
1
1
Physical Resistance
1
1
Detachment of Device or Device Component
1
1
Device Emits Odor
1
1
Mechanical Problem
1
1
Break
1
1
Unintended Movement
1
1
Loss of Threshold
1
1
Loss of Power
1
1
Improper or Incorrect Procedure or Method
1
1
Loose or Intermittent Connection
1
1
Component Falling
1
1
Noise, Audible
1
1
Misassembly by Users
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Patient Involvement
12
12
No Known Impact Or Consequence To Patient
10
10
No Clinical Signs, Symptoms or Conditions
2
2
Abrasion
1
1
Laceration(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Hettich Instruments Management I
I
Jan-21-2010
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