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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device regulator, pressure, gas cylinder
Product CodeCAN
Regulation Number 868.2700
Device Class 1

MDR Year MDR Reports MDR Events
2019 20 20
2020 2 2
2021 6 6
2022 6 6
2023 19 19
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 17 17
Fire 11 11
Loose or Intermittent Connection 7 7
Improper Flow or Infusion 7 7
Gas/Air Leak 5 5
No Flow 4 4
Explosion 3 3
Detachment of Device or Device Component 3 3
Flare or Flash 3 3
Overheating of Device 3 3
Increase in Pressure 2 2
Use of Incorrect Control/Treatment Settings 2 2
Defective Component 2 2
Defective Device 2 2
Appropriate Term/Code Not Available 2 2
Separation Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Material Twisted/Bent 1 1
Medical Gas Supply Problem 1 1
Output Problem 1 1
Pressure Problem 1 1
Temperature Problem 1 1
Key or Button Unresponsive/not Working 1 1
Device Handling Problem 1 1
Physical Resistance/Sticking 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Deformation Due to Compressive Stress 1 1
Connection Problem 1 1
Failure to Cycle 1 1
Unexpected Therapeutic Results 1 1
Incorrect Measurement 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 24 24
No Known Impact Or Consequence To Patient 10 10
Insufficient Information 9 9
No Consequences Or Impact To Patient 5 5
Partial thickness (Second Degree) Burn 4 4
Low Oxygen Saturation 3 3
Superficial (First Degree) Burn 2 2
No Information 2 2
Cardiac Arrest 2 2
Death 1 1
Dyspnea 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Distress 1 1
Loss of consciousness 1 1
Bradycardia 1 1
Burn(s) 1 1
Convulsion/Seizure 1 1
Cough 1 1
Burn, Thermal 1 1
Full thickness (Third Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Western/Scott Fetzer Company II Apr-12-2023
2 Western/Scott Fetzer Company II Nov-19-2021
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