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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device urinometer, electrical
Product CodeEXS
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 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Volume Accuracy Problem 92 92
Device Sensing Problem 86 86
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
Computer Operating System Problem 12 12
Break 11 11
Failure to Calibrate 10 10
Circuit Failure 9 9
Intermittent Loss of Power 7 7
Material Fragmentation 7 7
Use of Device Problem 7 7
Defective Component 6 6
Inadequate or Insufficient Training 5 5
Defective Device 4 4
Failure to Power Up 4 4
Component Missing 4 4
Device Handling Problem 4 4
Fitting Problem 3 3
Failure to Sense 3 3
Material Protrusion/Extrusion 3 3
Incorrect Measurement 3 3
Overheating of Device 2 2
Nonstandard Device 2 2
Inaccurate Flow Rate 2 2
Material Twisted/Bent 2 2
Unable to Obtain Readings 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Alarm System 2 2
Output Problem 2 2
Calibration Problem 1 1
False Alarm 1 1
Misassembly During Maintenance/Repair 1 1
Detachment of Device or Device Component 1 1
Battery Problem 1 1
Patient Data Problem 1 1
Failure to Transmit Record 1 1
Device Dislodged or Dislocated 1 1
Appropriate Term/Code Not Available 1 1
Program or Algorithm Execution Failure 1 1
No Display/Image 1 1
Electrical /Electronic Property Problem 1 1
Loose or Intermittent Connection 1 1
Reset Problem 1 1
Inadequate User Interface 1 1
Temperature 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 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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