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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
Product CodeDTW
Regulation Number 870.4340
Device Class 2

MDR Year MDR Reports MDR Events
2019 15 15
2020 2 2
2021 2 2
2023 1 1
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Device Sensing Problem 5 5
Failure to Sense 4 4
Appropriate Term/Code Not Available 4 4
Failure to Power Up 2 2
Under-Sensing 1 1
Low Readings 1 1
Defective Alarm 1 1
Incorrect Measurement 1 1
Over-Sensing 1 1
Failure to Auto Stop 1 1
Output Problem 1 1
Insufficient Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 10 10
No Patient Involvement 7 7
No Clinical Signs, Symptoms or Conditions 5 5
Insufficient Information 1 1

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