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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device amplifier and signal conditioner, transducer signal
Product CodeDRQ
Regulation Number 870.2060
Device Class 2

MDR Year MDR Reports MDR Events
2020 5 5
2021 4 4
2022 6 6
2023 8 8
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Power Up 6 6
Defective Device 4 4
Material Integrity Problem 4 4
Operating System Becomes Nonfunctional 3 3
Device Displays Incorrect Message 3 3
Power Conditioning Problem 3 3
Signal Artifact/Noise 2 2
Communication or Transmission Problem 2 2
Device-Device Incompatibility 1 1
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21 21
No Consequences Or Impact To Patient 3 3
No Known Impact Or Consequence To Patient 3 3

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