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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
Device detector, bubble, cardiopulmonary bypass
Product CodeKRL
Regulation Number 870.4205
Device Class 2

MDR Year MDR Reports MDR Events
2018 2 2
2019 4 4
2022 20 20
2023 17 17
2024 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Low Readings 22 22
Device Sensing Problem 14 14
Over-Sensing 6 6
False Alarm 3 3
Under-Sensing 3 3
Unexpected Shutdown 2 2
Deflation Problem 2 2
Failure to Sense 2 2
Device Alarm System 1 1
Sensing Intermittently 1 1
Disconnection 1 1
Fracture 1 1
Difficult to Open or Close 1 1
Appropriate Term/Code Not Available 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 40 40
No Consequences Or Impact To Patient 4 4
No Patient Involvement 2 2
Air Embolism 1 1

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