TPLC - Total Product Life Cycle

• 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
SAN CHEONG CO. LTD.
	SUBSTANTIALLY EQUIVALENT	1
1.  K080243  PORTABLE OXYGEN UNIT SCA900

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