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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
Use of Device Problem 7 7
Charging Problem 7 7
Crack 6 6
Detachment of Device or Device Component 5 5
Material Integrity Problem 5 5
Difficult to Remove 4 4
Melted 4 4
Device-Device Incompatibility 4 4
Excessive Heating 4 4
Mechanical Jam 4 4
Fumes or Vapors 3 3
Physical Resistance/Sticking 3 3
Noise, Audible 3 3
Smoking 3 3
Premature Discharge of Battery 3 3
Explosion 3 3
Fail-Safe Problem 3 3
Device Fell 3 3
Vibration 3 3
Power Problem 2 2
Visual Prompts will not Clear 2 2
No Apparent Adverse Event 2 2
Unintended Ejection 1 1
Therapeutic or Diagnostic Output Failure 1 1
Component Missing 1 1
Output below Specifications 1 1
Connection Problem 1 1
Sparking 1 1
Improper or Incorrect Procedure or Method 1 1
Device Slipped 1 1
Packaging Problem 1 1
Defective Device 1 1
Insufficient Information 1 1
Output Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Alarm System 1 1
Positioning Problem 1 1
Unintended Movement 1 1
Environmental Particulates 1 1
Failure to Power Up 1 1
Separation Failure 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
Bone Fracture(s) 1 1
Death 1 1
Injury 1 1

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