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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

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
Flare or Flash 3 3
Overheating of Device 3 3
Therapeutic or Diagnostic Output Failure 2 2
Appropriate Term/Code Not Available 2 2
Use of Incorrect Control/Treatment Settings 2 2
Sparking 1 1
Device Operates Differently Than Expected 1 1
Infusion or Flow Problem 1 1
Protective Measures Problem 1 1
Device Handling Problem 1 1
Medical Gas Supply Problem 1 1
Pressure Problem 1 1
Physical Resistance/Sticking 1 1
Excessive Heating 1 1
Leak/Splash 1 1
Unexpected Therapeutic Results 1 1
Defective Component 1 1
Noise, Audible 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Smoking 1 1
Inaccurate Delivery 1 1
Defective Device 1 1
Deformation Due to Compressive Stress 1 1
Output Problem 1 1
Temperature Problem 1 1
Incorrect Measurement 1 1
Nonstandard Device 1 1
Device Displays Incorrect Message 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 Clinical Signs, Symptoms or Conditions 3 3
No Information 3 3
Burn(s) 2 2
Insufficient Information 2 2
Superficial (First Degree) Burn 2 2
Cough 1 1
Cardiac Arrest 1 1
Respiratory Distress 1 1
Discomfort 1 1
Burn, Thermal 1 1
Full thickness (Third Degree) Burn 1 1
Dyspnea 1 1
Low Blood Pressure/ Hypotension 1 1
Low Oxygen Saturation 1 1
Convulsion/Seizure 1 1
Bradycardia 1 1
Death 1 1
Bone Fracture(s) 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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