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 CARE MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
FOSHAN MIC MEDICAL TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K191875 Owgels Oxygen Concentrator
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
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
LONGFIAN SCITECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MOLECULAR PRODUCTS 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	141	141
Adverse Event Without Identified Device or Use Problem	140	140
Overheating of Device	135	135
Low Readings	107	107
Use of Device Problem	77	77
Insufficient Information	76	80
Thermal Decomposition of Device	75	75
No Audible Alarm	71	71
Explosion	49	49
Temperature Problem	45	45
Melted	42	42
No Flow	40	40
Noise, Audible	37	37
Electrical /Electronic Property Problem	35	35
Unexpected Shutdown	35	35
Smoking	34	34
Insufficient Flow or Under Infusion	30	30
Material Deformation	29	29
Improper or Incorrect Procedure or Method	27	27
Battery Problem	26	26
Device Emits Odor	25	25
Contamination	25	25
Power Problem	24	24
Excessive Heating	23	23
Output Problem	22	22
Infusion or Flow Problem	22	22
Failure to Deliver	22	22
Gas Output Problem	21	21
Mechanical Problem	21	21
Device Alarm System	20	20
Crack	20	20
Particulates	19	19
Improper Flow or Infusion	17	17
Failure to Power Up	17	17
No Apparent Adverse Event	16	16
Degraded	16	16
Sparking	15	15
Gas/Air Leak	14	14
Appropriate Term/Code Not Available	12	12
Device Contamination with Chemical or Other Material	12	12
Failure to Charge	12	12
Material Integrity Problem	11	11
Therapeutic or Diagnostic Output Failure	10	10
Disconnection	10	10
Defective Alarm	10	10
Electrical Shorting	10	10
Intermittent Loss of Power	9	9
Material Discolored	9	9
Complete Loss of Power	9	9
Break	9	9

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	805	809
Low Oxygen Saturation	119	119
Burn(s)	113	113
Insufficient Information	98	98
No Consequences Or Impact To Patient	72	72
Death	44	44
Unspecified Respiratory Problem	43	43
Partial thickness (Second Degree) Burn	42	42
Dyspnea	42	42
No Known Impact Or Consequence To Patient	24	24
Hypoxia	22	22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	20	20
Full thickness (Third Degree) Burn	20	20
Superficial (First Degree) Burn	18	18
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
Hypersensitivity/Allergic reaction	8	8
Swelling/ Edema	8	8
Pain	8	8
Discomfort	6	6
No Information	6	6
Distress	5	5
Unspecified Heart Problem	5	5
Unspecified Kidney or Urinary Problem	5	5
Respiratory Tract Infection	5	5
Erythema	5	5
Inflammation	5	5
Burning Sensation	5	5
Muscle Weakness	5	5
Fall	4	4
Viral Infection	4	4
Cognitive Changes	4	4
Arthralgia	3	3
Increased Sensitivity	3	3
Itching Sensation	3	3
Cough	3	3
Confusion/ Disorientation	3	3
Bruise/Contusion	3	3
Chronic Obstructive Pulmonary Disease (COPD)	3	3
Respiratory Failure	3	3
Loss of consciousness	3	3
Cyanosis	3	3
Respiratory Insufficiency	3	3
Respiratory Arrest	3	3
Emotional Changes	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Caire, Inc.	II	Nov-15-2024
2	Caire, Inc.	II	May-19-2022
3	Caire, Inc.	II	Jan-13-2020
4	Caire, Inc.	II	Oct-30-2019
5	DeVilbiss Healthcare LLC	II	May-04-2023
6	DeVilbiss Healthcare LLC	II	Dec-19-2022
7	DeVilbiss Healthcare LLC	II	Nov-11-2022
8	Invacare Corporation	III	Jul-12-2022
9	Invacare Corporation	II	Dec-01-2020
10	JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO LTD	I	Jan-03-2025