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TPLC
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show TPLC since
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Device
regulator, pressure, gas cylinder
Product Code
CAN
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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