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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 22 22
Fire 11 11
Loose or Intermittent Connection 7 7
Improper Flow or Infusion 7 7
Gas/Air Leak 5 5
No Flow 4 4
Detachment of Device or Device Component 3 3
Flare or Flash 3 3
Explosion 3 3
Overheating of Device 3 3
Increase in Pressure 2 2
Defective Component 2 2
Defective Device 2 2
Use of Incorrect Control/Treatment Settings 2 2
Appropriate Term/Code Not Available 2 2
Therapeutic or Diagnostic Output Failure 2 2
Misassembly by Users 2 2
Separation Problem 2 2
Inaccurate Information 1 1
Key or Button Unresponsive/not Working 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Device Handling Problem 1 1
Physical Resistance/Sticking 1 1
Device Contamination with Chemical or Other Material 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
Failure to Cycle 1 1
Fracture 1 1
Incorrect Measurement 1 1
Nonstandard Device 1 1
Device Emits Odor 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Deformation Due to Compressive Stress 1 1
Connection Problem 1 1
Unexpected Therapeutic Results 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 42 42
Insufficient Information 11 11
No Known Impact Or Consequence To Patient 10 10
Low Oxygen Saturation 6 6
No Consequences Or Impact To Patient 5 5
Partial thickness (Second Degree) Burn 4 4
Superficial (First Degree) Burn 2 2
No Information 2 2
Dyspnea 2 2
Cardiac Arrest 2 2
Death 1 1
Bradycardia 1 1
Burn(s) 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Distress 1 1
Loss of consciousness 1 1
Convulsion/Seizure 1 1
Cough 1 1
Full thickness (Third Degree) Burn 1 1
Burn, Thermal 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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