• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device battery, replacement, rechargeable
Product CodeMOQ
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2019 78 78
2020 120 120
2021 123 123
2022 860 860
2023 125 125
2024 36 36

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 945 945
Complete Loss of Power 79 79
Mechanical Problem 48 48
Appropriate Term/Code Not Available 41 41
Unintended System Motion 35 35
Fracture 35 35
Break 28 28
Failure to Charge 23 23
Fire 19 19
Overheating of Device 17 17
Unexpected Shutdown 16 16
Fail-Safe Did Not Operate 15 15
Premature Separation 12 12
Fluid/Blood Leak 11 11
Leak/Splash 11 11
Electrical /Electronic Property Problem 9 9
Use of Device Problem 7 7
Charging Problem 7 7
Difficult to Open or Close 7 7
Crack 6 6
Detachment of Device or Device Component 5 5
Material Integrity Problem 5 5
Mechanical Jam 4 4
Device-Device Incompatibility 4 4
Melted 4 4
Excessive Heating 4 4
Smoking 3 3
Noise, Audible 3 3
Explosion 3 3
Physical Resistance/Sticking 3 3
Device Fell 3 3
Vibration 3 3
Premature Discharge of Battery 3 3
Fumes or Vapors 3 3
Visual Prompts will not Clear 2 2
Difficult to Remove 2 2
Fail-Safe Problem 2 2
Power Problem 2 2
No Apparent Adverse Event 2 2
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Failure to Power Up 1 1
Unintended Ejection 1 1
Component Missing 1 1
Connection Problem 1 1
Separation Failure 1 1
Defective Device 1 1
Sparking 1 1
Environmental Particulates 1 1
Output below Specifications 1 1
Output Problem 1 1
Packaging Problem 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1026 1026
Insufficient Information 159 159
No Consequences Or Impact To Patient 94 94
No Patient Involvement 44 44
No Known Impact Or Consequence To Patient 23 23
No Information 9 9
No Code Available 2 2
Injury 1 1
Death 1 1
Bone Fracture(s) 1 1

-
-