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TPLC
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Device
fluorometer, for clinical use
Regulation Description
Fluorometer for clinical use.
Product Code
KHO
Regulation Number
862.2560
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
257
257
2021
213
213
2022
224
224
2023
260
260
2024
168
168
2025
12
12
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
603
603
Incorrect, Inadequate or Imprecise Result or Readings
174
174
Electrical /Electronic Property Problem
44
44
Failure to Align
40
40
Obstruction of Flow
29
29
High Readings
24
24
High Test Results
21
21
Fluid/Blood Leak
15
15
Infusion or Flow Problem
14
14
Noise, Audible
13
13
Leak/Splash
12
12
Mechanical Jam
12
12
Loose or Intermittent Connection
11
11
Display or Visual Feedback Problem
11
11
Temperature Problem
9
9
Low Readings
8
8
Output Problem
8
8
Material Twisted/Bent
8
8
Low Test Results
8
8
Non Reproducible Results
7
7
Suction Failure
6
6
Failure to Pump
6
6
Computer Software Problem
6
6
Decreased Sensitivity
6
6
No Flow
5
5
Priming Problem
5
5
Suction Problem
5
5
Intermittent Continuity
5
5
Electrical Power Problem
5
5
Air/Gas in Device
4
4
Break
4
4
Image Display Error/Artifact
4
4
Use of Device Problem
3
3
Communication or Transmission Problem
3
3
Detachment of Device or Device Component
3
3
Material Deformation
3
3
Complete Blockage
3
3
Electrical Shorting
3
3
Patient Data Problem
3
3
Data Problem
3
3
Display Difficult to Read
3
3
Pressure Problem
3
3
Intermittent Communication Failure
2
2
Loss of Power
2
2
Failure to Deliver
2
2
Device Sensing Problem
2
2
Disconnection
2
2
Partial Blockage
2
2
Degraded
2
2
Device Ingredient or Reagent Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
936
936
No Known Impact Or Consequence To Patient
187
187
Insufficient Information
10
10
Missing Value Reason
1
1
Electric Shock
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Tosoh Bioscience Inc
II
Jun-23-2020
2
Tosoh Bioscience Inc
II
Feb-11-2020
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