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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 958 958
Complete Loss of Power 79 79
Mechanical Problem 53 53
Fracture 45 45
Appropriate Term/Code Not Available 44 44
Unintended System Motion 37 37
Break 30 30
Failure to Charge 24 24
Fire 20 20
Overheating of Device 18 18
Unexpected Shutdown 16 16
Fail-Safe Did Not Operate 15 15
Premature Separation 13 13
Fluid/Blood Leak 12 12
Leak/Splash 11 11
Difficult to Open or Close 11 11
Electrical /Electronic Property Problem 9 9
Charging Problem 7 7
Use of Device Problem 7 7
Crack 6 6
Detachment of Device or Device Component 5 5
Material Integrity Problem 5 5
Mechanical Jam 4 4
Excessive Heating 4 4
Device-Device Incompatibility 4 4
Melted 4 4
Difficult to Remove 4 4
Premature Discharge of Battery 3 3
Fail-Safe Problem 3 3
Vibration 3 3
Fumes or Vapors 3 3
Smoking 3 3
Noise, Audible 3 3
Explosion 3 3
Physical Resistance/Sticking 3 3
Device Fell 3 3
Power Problem 2 2
No Apparent Adverse Event 2 2
Visual Prompts will not Clear 2 2
Component Missing 1 1
Improper or Incorrect Procedure or Method 1 1
Separation Failure 1 1
Defective Device 1 1
Sparking 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Environmental Particulates 1 1
Connection Problem 1 1
Device Alarm System 1 1
Unintended Ejection 1 1
Device Slipped 1 1
Failure to Power Up 1 1
Insufficient Information 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 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 1071 1071
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

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