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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 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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