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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
washer of body waste receptacles
Product Code
FLH
Regulation Number
880.6800
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
8
8
2015
9
9
2016
1
1
2017
6
6
2019
6
6
2020
5
5
2021
5
5
2022
6
6
2023
9
9
Device Problems
MDRs with this Device Problem
Events in those MDRs
Fire
10
10
Fluid/Blood Leak
6
6
Use of Device Problem
6
6
Leak/Splash
5
5
Device Emits Odor
4
4
Device Displays Incorrect Message
4
4
Adverse Event Without Identified Device or Use Problem
4
4
Incorrect, Inadequate or Imprecise Result or Readings
3
3
Smoking
3
3
Defective Component
2
2
Break
2
2
Device Operates Differently Than Expected
2
2
Electrical Shorting
2
2
Insufficient Information
2
2
Noise, Audible
1
1
Failure to Auto Stop
1
1
Gas/Air Leak
1
1
Installation-Related Problem
1
1
Material Deformation
1
1
Material Integrity Problem
1
1
Moisture or Humidity Problem
1
1
Difficult to Open or Close
1
1
Output Problem
1
1
Temperature Problem
1
1
Thermal Decomposition of Device
1
1
Charred
1
1
Electrical /Electronic Property Problem
1
1
Overheating of Device
1
1
Off-Label Use
1
1
Fumes or Vapors
1
1
Sparking
1
1
Material Frayed
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
12
12
No Clinical Signs, Symptoms or Conditions
12
12
Injury
4
4
Sore Throat
4
4
Electric Shock
3
3
Insufficient Information
2
2
No Consequences Or Impact To Patient
2
2
Fall
2
2
Laceration(s)
1
1
Bruise/Contusion
1
1
Burn(s)
1
1
Physical Entrapment
1
1
Discomfort
1
1
Caustic/Chemical Burns
1
1
Blister
1
1
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