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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device box, battery, rechargeable
Product CodeFCO
Regulation Number 876.1500
Device Class 1

MDR Year MDR Reports MDR Events
2014 2 2
2015 3 3
2016 18 18
2017 2 2
2020 1 1
2023 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 12 12
Smoking 6 6
Electrical /Electronic Property Problem 5 5
Fire 5 5
Device Emits Odor 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Noise, Audible 2 2
Sparking 2 2
Thermal Decomposition of Device 1 1
Overheating of Device 1 1
Material Rupture 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 11 11
No Patient Involvement 9 9
No Information 8 8
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 3 3
Low Blood Pressure/ Hypotension 1 1
Respiratory Distress 1 1
No Code Available 1 1

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