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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cylinder, compressed gas, and valve
Product CodeECX
Regulation Number 868.2700
Device Class 1

MDR Year MDR Reports MDR Events
2019 1 1
2020 1 1
2021 4 4
2022 1 1
2023 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 2 2
Incorrect Measurement 1 1
Product Quality Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Failure to Deliver 1 1
High Readings 1 1
Electrical Shorting 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Output Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Low Oxygen Saturation 3 3
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 1 1
Cardiac Arrest 1 1
Cyanosis 1 1
Low Blood Pressure/ Hypotension 1 1
Cognitive Changes 1 1
No Patient Involvement 1 1
Respiratory Arrest 1 1
Unspecified Respiratory Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Western / Scott Fetzer Company II Nov-06-2019
2 Western/Scott Fetzer Company II Nov-19-2021
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