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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
2018 238 238
2019 20 20
2020 2 2
2021 6 6
2022 6 6
2023 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 142 142
Break 139 139
Device Emits Odor 137 137
High Test Results 127 127
Loose or Intermittent Connection 96 96
Improper Flow or Infusion 96 96
Increase in Pressure 91 91
Separation Problem 90 90
Fire 10 10
Detachment of Device or Device Component 5 5
Explosion 4 4
Material Separation 4 4
Overheating of Device 3 3
Flare or Flash 3 3
Use of Incorrect Control/Treatment Settings 2 2
Appropriate Term/Code Not Available 2 2
Therapeutic or Diagnostic Output Failure 2 2
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Device Operates Differently Than Expected 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Physical Resistance/Sticking 1 1
Excessive Heating 1 1
Infusion or Flow Problem 1 1
Medical Gas Supply Problem 1 1
Output Problem 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Temperature Problem 1 1
Gas Output Problem 1 1
Leak/Splash 1 1
Incorrect Measurement 1 1
Nonstandard Device 1 1
Smoking 1 1
Unexpected Therapeutic Results 1 1
Defective Component 1 1
Inaccurate Delivery 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Deformation Due to Compressive Stress 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 244 244
No Consequences Or Impact To Patient 6 6
Partial thickness (Second Degree) Burn 4 4
No Information 3 3
Insufficient Information 3 3
No Clinical Signs, Symptoms or Conditions 3 3
Superficial (First Degree) Burn 2 2
Burn(s) 2 2
Cardiac Arrest 1 1
Death 1 1
Dyspnea 1 1
Bone Fracture(s) 1 1
Low Blood Pressure/ Hypotension 1 1
Respiratory Distress 1 1
Discomfort 1 1
Low Oxygen Saturation 1 1
Burn, Thermal 1 1
Bradycardia 1 1
Full thickness (Third Degree) Burn 1 1
Convulsion/Seizure 1 1
Cough 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Dynarex Corporation II May-29-2018
2 Western/Scott Fetzer Company II Nov-19-2021
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