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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device calibrator, hearing aid / earphone and analysis systems
Regulation Description Hearing aid calibrator and analysis system.
Product CodeETW
Regulation Number 874.3310
Device Class 2

MDR Year MDR Reports MDR Events
2019 5 5
2020 4 4
2021 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Battery Problem 9 9
Overheating of Device 5 5
Explosion 3 3
Battery 3 3
Defective Device 1 1
Electrical Overstress 1 1
Insufficient Information 1 1
Component Incompatible 1 1
Melted 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10 10
Not Applicable 7 7
No Known Impact Or Consequence To Patient 3 3

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