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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device flowmeter, nonback-pressure compensated, bourdon gauge
Product CodeCCN
Regulation Number 868.2300
Device Class 1

MDR Year MDR Reports MDR Events
2015 1 1
2018 2 2
2020 29 29
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
No Flow 18 18
Failure to Deliver 8 8
Leak/Splash 6 6
Material Deformation 6 6
Incorrect, Inadequate or Imprecise Result or Readings 3 3
Device Dislodged or Dislocated 2 2
Infusion or Flow Problem 2 2
Detachment Of Device Component 1 1
Inaccurate Delivery 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 29 29
Death 2 2
Low Oxygen Saturation 2 2
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Amvex Corporation II Aug-21-2009
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