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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
Premarket Reviews
Manufacturer
Decision
ESSEX INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
1. K162811
MR Conditional CGA 870
SAN CHEONG CO. LTD.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
11
11
2015
12
12
2016
13
13
2017
11
11
2018
238
238
2019
20
20
2020
2
2
2021
6
6
2022
6
6
2023
19
19
2024
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
143
143
Gas/Air Leak
143
143
Device Emits Odor
137
137
High Test Results
127
127
Improper Flow or Infusion
98
98
Loose or Intermittent Connection
96
96
Increase in Pressure
91
91
Separation Problem
90
90
Gas Output Problem
17
17
Fire
16
16
Device Operates Differently Than Expected
9
9
Flare or Flash
7
7
Adverse Event Without Identified Device or Use Problem
7
7
Detachment of Device or Device Component
7
7
No Flow
6
6
Infusion or Flow Problem
6
6
Material Separation
5
5
Burst Container or Vessel
5
5
Explosion
4
4
Device Handling Problem
3
3
Overheating of Device
3
3
Inaccurate Flow Rate
2
2
Leak/Splash
2
2
Detachment Of Device Component
2
2
Use of Incorrect Control/Treatment Settings
2
2
Crack
2
2
Device Inoperable
2
2
Use of Device Problem
2
2
Connection Problem
2
2
Sparking
2
2
Defective Device
2
2
Defective Component
2
2
Noise, Audible
2
2
Medical Gas Supply Problem
2
2
Therapeutic or Diagnostic Output Failure
2
2
Insufficient Information
2
2
Appropriate Term/Code Not Available
2
2
No Apparent Adverse Event
1
1
Output Problem
1
1
Pressure Problem
1
1
Protective Measures Problem
1
1
Temperature Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Material Twisted/Bent
1
1
Mechanics Altered
1
1
Physical Resistance/Sticking
1
1
Excessive Heating
1
1
Key or Button Unresponsive/not Working
1
1
Failure to Deliver
1
1
Inaccurate Delivery
1
1
Device Displays Incorrect Message
1
1
Deformation Due to Compressive Stress
1
1
Improper or Incorrect Procedure or Method
1
1
Device Damaged Prior to Use
1
1
Smoking
1
1
Unexpected Therapeutic Results
1
1
Material Rupture
1
1
Failure to Cycle
1
1
Display or Visual Feedback Problem
1
1
Component Falling
1
1
Incorrect Measurement
1
1
Nonstandard Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
256
256
No Clinical Signs, Symptoms or Conditions
24
24
No Consequences Or Impact To Patient
10
10
Burn(s)
9
9
Insufficient Information
9
9
No Patient Involvement
6
6
Partial thickness (Second Degree) Burn
5
5
No Information
5
5
Cardiac Arrest
5
5
Superficial (First Degree) Burn
4
4
Low Oxygen Saturation
3
3
Brain Injury
3
3
Necrosis
3
3
Injury
2
2
Not Applicable
2
2
Full thickness (Third Degree) Burn
1
1
Burn, Thermal
1
1
Bowel Perforation
1
1
Convulsion/Seizure
1
1
Cough
1
1
Loss of consciousness
1
1
Discomfort
1
1
Perforation
1
1
Respiratory Distress
1
1
Abscess
1
1
Anoxia
1
1
Bradycardia
1
1
Cardiopulmonary Arrest
1
1
Cellulitis
1
1
Cyst(s)
1
1
Death
1
1
Dyspnea
1
1
Bone Fracture(s)
1
1
Hemorrhage/Bleeding
1
1
Low Blood Pressure/ Hypotension
1
1
Hypoxia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Airgas Puritan Medical
II
Oct-14-2009
2
Dynarex Corporation
II
May-29-2018
3
Linde Gas North America Llc
II
Jun-20-2013
4
Praxair Inc.
I
Dec-21-2012
5
Precision Medical, Inc.
II
Nov-13-2015
6
Western - a Scott Fetzer Company
II
Oct-15-2009
7
Western / Scott Fetzer Company
I
Jul-20-2015
8
Western / Scott Fetzer Company
II
Jun-23-2014
9
Western/Scott Fetzer Company
II
Apr-12-2023
10
Western/Scott Fetzer Company
II
Nov-19-2021
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