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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device manometer, blood-pressure, venous
Regulation Description Venous blood pressure manometer.
Product CodeKRK
Regulation Number 870.1140
Device Class 2

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Unable to Obtain Readings 1 1
No Device Output 1 1
Unsealed Device Packaging 1 1
Deformation Due to Compressive Stress 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1 1
Low Oxygen Saturation 1 1
No Patient Involvement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Carefusion 2200 Inc II Apr-18-2018
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