TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
3B MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
BELLUSCURA LLC
	SUBSTANTIALLY EQUIVALENT	1
CONTEC MEDICAL SYSTEM CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN MIC MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
INOGEN
	SUBSTANTIALLY EQUIVALENT	1
INOGEN, INC
	SUBSTANTIALLY EQUIVALENT	1
INVACARE CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K223740 Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LONGFIAN SCITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
NIDEK MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
OXUS, INC.
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO.
	SUBSTANTIALLY EQUIVALENT	1
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
ZHENGZHOU OLIVE ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fire	129	129
Adverse Event Without Identified Device or Use Problem	129	129
Overheating of Device	122	122
Low Readings	107	107
Use of Device Problem	72	72
No Audible Alarm	71	71
Thermal Decomposition of Device	63	63
Insufficient Information	62	66
Explosion	49	49
Melted	41	41
Noise, Audible	37	37
No Flow	34	34
Unexpected Shutdown	34	34
Temperature Problem	33	33
Smoking	33	33
Electrical /Electronic Property Problem	32	32
Insufficient Flow or Under Infusion	30	30
Material Deformation	29	29
Improper or Incorrect Procedure or Method	23	23
Output Problem	22	22
Device Emits Odor	22	22
Gas Output Problem	21	21
Infusion or Flow Problem	21	21
Contamination	20	20
Crack	20	20
Device Alarm System	20	20
Mechanical Problem	19	19
Failure to Deliver	19	19
Power Problem	18	18
Particulates	18	18
Excessive Heating	17	17
Improper Flow or Infusion	17	17
Failure to Power Up	17	17
Degraded	16	16
Sparking	15	15
No Apparent Adverse Event	14	14
Battery Problem	14	14
Gas/Air Leak	13	13
Device Contamination with Chemical or Other Material	12	12
Appropriate Term/Code Not Available	12	12
Material Integrity Problem	11	11
Defective Alarm	10	10
Therapeutic or Diagnostic Output Failure	10	10
Disconnection	10	10
Electrical Shorting	9	9
Break	9	9
Intermittent Loss of Power	9	9
Material Discolored	9	9
Complete Loss of Power	8	8
Failure to Charge	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	732	736
Low Oxygen Saturation	116	116
Burn(s)	103	103
Insufficient Information	85	85
No Consequences Or Impact To Patient	72	72
Death	44	44
Unspecified Respiratory Problem	42	42
Partial thickness (Second Degree) Burn	38	38
Dyspnea	32	32
No Known Impact Or Consequence To Patient	24	24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Full thickness (Third Degree) Burn	17	17
Superficial (First Degree) Burn	16	16
No Patient Involvement	16	16
Headache	12	12
Pneumonia	11	11
Patient Problem/Medical Problem	9	9
Dizziness	9	9
Skin Inflammation/ Irritation	9	9
Aspiration/Inhalation	9	9
Swelling/ Edema	8	8
Hypersensitivity/Allergic reaction	8	8
Pain	8	8
Hypoxia	7	7
No Information	6	6
Unspecified Kidney or Urinary Problem	5	5
Distress	5	5
Unspecified Heart Problem	5	5
Respiratory Tract Infection	5	5
Discomfort	5	5
Erythema	5	5
Inflammation	5	5
Muscle Weakness	5	5
Fall	4	4
Viral Infection	4	4
Burning Sensation	4	4
Cognitive Changes	4	4
Cough	3	3
Confusion/ Disorientation	3	3
Chronic Obstructive Pulmonary Disease (COPD)	3	3
Loss of consciousness	3	3
Respiratory Insufficiency	3	3
Itching Sensation	3	3
Respiratory Failure	3	3
Respiratory Arrest	3	3
Respiratory Distress	3	3
Emotional Changes	3	3
Increased Sensitivity	3	3
Arthralgia	3	3
Cyanosis	3	3