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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
2019
18
18
2020
13
13
2021
33
33
2022
226
226
2023
97
97
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Volume Accuracy Problem
90
90
Device Sensing Problem
84
84
Display or Visual Feedback Problem
47
47
Component Misassembled
33
33
Computer Software Problem
32
32
Operating System Becomes Nonfunctional
24
24
Restricted Flow rate
20
20
Erratic or Intermittent Display
12
12
Incorrect, Inadequate or Imprecise Result or Readings
12
12
Break
11
11
Failure to Calibrate
10
10
Computer Operating System Problem
8
8
Circuit Failure
8
8
Material Fragmentation
7
7
Use of Device Problem
7
7
Intermittent Loss of Power
7
7
Defective Component
6
6
Inadequate or Insufficient Training
5
5
Component Missing
4
4
Defective Device
4
4
Failure to Power Up
4
4
Device Handling Problem
4
4
Material Protrusion/Extrusion
3
3
Incorrect Measurement
3
3
Fitting Problem
3
3
Failure to Sense
3
3
Nonstandard Device
2
2
Overheating of Device
2
2
Unable to Obtain Readings
2
2
Inaccurate Flow Rate
2
2
Device Alarm System
2
2
Material Twisted/Bent
2
2
Therapeutic or Diagnostic Output Failure
2
2
Output Problem
2
2
Reset Problem
1
1
Temperature Problem
1
1
Appropriate Term/Code Not Available
1
1
Patient Data Problem
1
1
Program or Algorithm Execution Failure
1
1
Misassembly During Maintenance/Repair
1
1
False Alarm
1
1
No Display/Image
1
1
Electrical /Electronic Property Problem
1
1
Loose or Intermittent Connection
1
1
Failure to Transmit Record
1
1
Battery Problem
1
1
Calibration Problem
1
1
Detachment of Device or Device Component
1
1
Device Dislodged or Dislocated
1
1
Inadequate User Interface
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
264
264
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
102
102
No Known Impact Or Consequence To Patient
24
24
No Patient Involvement
15
15
No Consequences Or Impact To Patient
10
10
Insufficient Information
4
4
No Information
2
2
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
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