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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 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Gas Output Problem 26 26
Fire 11 11
Loose or Intermittent Connection 7 7
Gas/Air Leak 7 7
Improper Flow or Infusion 7 7
No Flow 4 4
Explosion 4 4
Insufficient Information 3 3
Flare or Flash 3 3
Overheating of Device 3 3
Detachment of Device or Device Component 3 3
Separation Problem 2 2
Defective Component 2 2
Defective Device 2 2
Therapeutic or Diagnostic Output Failure 2 2
Use of Incorrect Control/Treatment Settings 2 2
Misassembly by Users 2 2
Appropriate Term/Code Not Available 2 2
Increase in Pressure 2 2
Temperature Problem 1 1
Deformation Due to Compressive Stress 1 1
Device Displays Incorrect Message 1 1
Improper or Incorrect Procedure or Method 1 1
Inaccurate Information 1 1
Connection Problem 1 1
Unexpected Therapeutic Results 1 1
Nonstandard Device 1 1
Failure to Cycle 1 1
Medical Gas Supply Problem 1 1
Fracture 1 1
No Apparent Adverse Event 1 1
Device Contamination with Chemical or Other Material 1 1
Device Emits Odor 1 1
Incorrect Measurement 1 1
Device Handling Problem 1 1
Material Twisted/Bent 1 1
Use of Device Problem 1 1
Key or Button Unresponsive/not Working 1 1
High Readings 1 1
Physical Resistance/Sticking 1 1
Output Problem 1 1
Pressure Problem 1 1
Sparking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 50 50
Insufficient Information 22 22
No Known Impact Or Consequence To Patient 10 10
Low Oxygen Saturation 8 8
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
Cardiac Arrest 2 2
Burn(s) 2 2
Dyspnea 2 2
Full thickness (Third Degree) Burn 2 2
Death 1 1
Respiratory Distress 1 1
Burn, Thermal 1 1
Bradycardia 1 1
Cough 1 1
Convulsion/Seizure 1 1
Loss of consciousness 1 1
Low Blood Pressure/ Hypotension 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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