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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor and/or control, level sensing, cardiopulmonary bypass
Regulation Description Cardiopulmonary bypass level sensing monitor and/or control.
Product CodeDTW
Regulation Number 870.4340
Device Class 2

MDR Year MDR Reports MDR Events
2020 2 2
2021 2 2
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Sensing Problem 2 2
Incorrect Measurement 1 1
Under-Sensing 1 1
Output Problem 1 1
Failure to Sense 1 1
Failure to Power Up 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5 5
No Consequences Or Impact To Patient 2 2
Insufficient Information 1 1

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