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TPLC
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show TPLC since
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2024
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Device
urinometer, electrical
Product Code
EXS
Regulation Number
876.1800
Device Class
2
MDR Year
MDR Reports
MDR Events
2017
29
29
2018
16
16
2019
18
18
2020
13
13
2021
33
33
2022
226
226
2023
97
97
2024
10
10
Device Problems
MDRs with this Device Problem
Events in those MDRs
Volume Accuracy Problem
99
99
Device Sensing Problem
88
88
Display or Visual Feedback Problem
50
50
Component Misassembled
33
33
Computer Software Problem
32
32
Operating System Becomes Nonfunctional
24
24
Incorrect, Inadequate or Imprecise Result or Readings
21
21
Restricted Flow rate
20
20
Erratic or Intermittent Display
13
13
Computer Operating System Problem
12
12
Break
12
12
Circuit Failure
10
10
Incorrect Measurement
10
10
Failure to Calibrate
10
10
Use of Device Problem
7
7
Material Fragmentation
7
7
Intermittent Loss of Power
7
7
Defective Component
6
6
Failure to Power Up
5
5
Unable to Obtain Readings
5
5
Inadequate or Insufficient Training
5
5
Device Handling Problem
4
4
Improper Flow or Infusion
4
4
Component Missing
4
4
Defective Device
4
4
Device Displays Incorrect Message
4
4
Device Operates Differently Than Expected
4
4
Fitting Problem
3
3
Failure to Sense
3
3
Inaccurate Flow Rate
3
3
Material Protrusion/Extrusion
3
3
Application Interface Becomes Non-Functional Or Program Exits Abnormally
2
2
Data Problem
2
2
Calibration Problem
2
2
Incorrect Or Inadequate Test Results
2
2
Material Twisted/Bent
2
2
Temperature Problem
2
2
Overheating of Device
2
2
Nonstandard Device
2
2
Device Dislodged or Dislocated
2
2
Therapeutic or Diagnostic Output Failure
2
2
Device Alarm System
2
2
Device Markings/Labelling Problem
2
2
Output Problem
2
2
Improper Device Output
2
2
Appropriate Term/Code Not Available
1
1
Labelling, Instructions for Use or Training Problem
1
1
Detachment of Device or Device Component
1
1
Misassembly During Maintenance/Repair
1
1
Battery Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
271
271
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
104
104
No Known Impact Or Consequence To Patient
55
55
No Patient Involvement
21
21
No Consequences Or Impact To Patient
21
21
No Information
12
12
Insufficient Information
4
4
Cramp(s) /Muscle Spasm(s)
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
C.R. Bard Inc
II
Dec-14-2023
2
C.R. Bard Inc
II
Jun-27-2022
3
C.R. Bard, Inc.
II
Jun-15-2018
4
C.R. Bard, Inc.
II
Feb-09-2018
5
C.R. Bard, Inc.
II
Jan-29-2018
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