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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device flowmeter, calibration, gas
Product CodeBXY
Regulation Number 868.2350
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2022 1 1
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 2 2
Crack 1 1
Fracture 1 1
Improper or Incorrect Procedure or Method 1 1
Detachment of Device or Device Component 1 1
Device Markings/Labelling Problem 1 1
Gas/Air Leak 1 1
Material Split, Cut or Torn 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 2 2
Respiratory Insufficiency 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Cardiac Arrest 1 1
Death 1 1

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