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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
2018 133 133
2019 78 78
2020 120 120
2021 123 123
2022 860 860
2023 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 907 907
Unintended System Motion 103 103
Fail-Safe Problem 74 74
Complete Loss of Power 70 70
Appropriate Term/Code Not Available 40 40
Mechanical Problem 39 39
Overheating of Device 25 25
Failure to Charge 25 25
Break 21 21
Unexpected Shutdown 20 20
Fire 18 18
Fluid/Blood Leak 16 16
Fail-Safe Did Not Operate 13 13
Premature Separation 10 10
Charging Problem 10 10
Melted 9 9
Fracture 9 9
Electrical /Electronic Property Problem 9 9
Device Operates Differently Than Expected 9 9
Leak/Splash 8 8
Use of Device Problem 6 6
Mechanical Jam 6 6
Smoking 5 5
Device Inoperable 5 5
Detachment of Device or Device Component 4 4
Excessive Heating 4 4
Device-Device Incompatibility 3 3
Difficult to Open or Close 3 3
Explosion 3 3
Physical Resistance/Sticking 3 3
Material Integrity Problem 3 3
Vibration 3 3
Fumes or Vapors 3 3
Separation Failure 3 3
Connection Problem 2 2
Defective Component 2 2
Visual Prompts will not Clear 2 2
Premature Discharge of Battery 2 2
Component Falling 2 2
No Apparent Adverse Event 2 2
Output below Specifications 2 2
Output Problem 1 1
Packaging Problem 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Environmental Particulates 1 1
Device Operational Issue 1 1
Device Damaged by Another Device 1 1
Insufficient Information 1 1
Noise, Audible 1 1
Crack 1 1
Degraded 1 1
Material Discolored 1 1
Unintended Ejection 1 1
Loose or Intermittent Connection 1 1
Failure to Power Up 1 1
Device Slipped 1 1
Aborted Charge 1 1
Improper or Incorrect Procedure or Method 1 1
Unstable 1 1
Device Emits Odor 1 1
Component Missing 1 1
Delayed Charge Time 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 909 909
No Consequences Or Impact To Patient 184 184
Insufficient Information 146 146
No Known Impact Or Consequence To Patient 58 58
No Patient Involvement 50 50
No Information 11 11
No Code Available 2 2
Injury 1 1
Death 1 1
Bone Fracture(s) 1 1
Blurred Vision 1 1

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