TPLC - Total Product Life Cycle

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Device	analyzer, gas, carbon-dioxide, gaseous-phase
Regulation Description	Carbon dioxide gas analyzer.
Product Code	CCK
Regulation Number	868.1400
Device Class	2

Premarket Reviews
Manufacturer	Decision
BARBARAS DEVELOPMENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
BEIJING KINGST COMMERCIAL & TRADE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
BLUEPOINT MEDICAL GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
CMI HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	2
DRAEGERWERK AG & CO KGAA
	SUBSTANTIALLY EQUIVALENT	1
ENDURE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENGINEERED MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXOSTAT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE FINLAND OY
	SUBSTANTIALLY EQUIVALENT	2
INVENTEUR, LLC
	SUBSTANTIALLY EQUIVALENT	1
MASIMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MAXTEC, LLC
	SUBSTANTIALLY EQUIVALENT	1
MEDIPINES CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDITERA TIBBI MALZEME SAN VE TIC AS
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ORANTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
ORIDION MEDICAL 1987 , LTD.
	SUBSTANTIALLY EQUIVALENT	3
PNEUMA THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
POM MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
1. K172365 Panoramic Oxygen Mask (POM)
PRIOR CARE SCIENCE TECHNOLOGY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
RESPIRION, INC.
	SUBSTANTIALLY EQUIVALENT	1
REVOLUTIONARY MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOUTHMEDIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
TYLENOL MEDICAL INSTRUMENTS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
UNIMED MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3524	3524
Communication or Transmission Problem	3227	3227
Crack	2694	2694
Corroded	1105	1106
Failure to Calibrate	1064	1064
Appropriate Term/Code Not Available	946	966
Device Alarm System	797	797
Incorrect, Inadequate or Imprecise Result or Readings	748	748
Calibration Problem	577	578
Computer Software Problem	565	565
Contamination	537	537
No Device Output	515	515
Failure of Device to Self-Test	497	498
Loose or Intermittent Connection	460	460
No Apparent Adverse Event	424	424
Circuit Failure	313	313
Insufficient Information	295	295
Output Problem	273	273
Device Sensing Problem	181	181
Unable to Obtain Readings	145	145
Physical Resistance/Sticking	138	138
Missing Information	125	125
Failure to Read Input Signal	111	111
Display or Visual Feedback Problem	111	111
Display Difficult to Read	78	78
Incorrect Measurement	71	71
Application Program Freezes, Becomes Nonfunctional	62	62
Low Readings	62	62
Inadequate or Insufficient Training	50	50
Misassembled	50	50
Gas Output Problem	49	49
High Readings	48	48
Image Display Error/Artifact	46	46
Failure to Power Up	40	40
Pumping Stopped	39	39
Peeled/Delaminated	38	38
Application Program Problem	32	32
Naturally Worn	28	28
Degraded	28	28
Electrical /Electronic Property Problem	26	26
Failure to Cycle	25	25
Power Problem	24	24
Mechanical Problem	22	22
No Display/Image	22	22
Temperature Problem	22	22
Noise, Audible	18	18
Unexpected Shutdown	17	17
Failure to Analyze Signal	17	17
Use of Device Problem	17	18
Device Markings/Labelling Problem	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8309	8331
No Patient Involvement	2990	2990
Insufficient Information	138	140
No Consequences Or Impact To Patient	132	132
No Known Impact Or Consequence To Patient	114	114
No Information	81	81
Unintended Extubation	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Cardiac Arrest	5	5
Unspecified Tissue Injury	4	4
Low Oxygen Saturation	4	4
Foreign Body In Patient	3	3
Respiratory Distress	2	2
Respiratory Failure	2	2
Death	2	2
Hypoxia	2	2
Laceration(s)	2	2
Pain	2	2
Perforation	1	1
Pressure Sores	1	1
Anxiety	1	1
Discomfort	1	1
Injury	1	1
Inadequate Pain Relief	1	1
Extubate	1	1
Hypersensitivity/Allergic reaction	1	1
Hypoventilation	1	1
Bacterial Infection	1	1
Bruise/Contusion	1	1
Cardiopulmonary Arrest	1	1
Chest Pain	1	1
Cyanosis	1	1
Lethargy	1	1
Superficial (First Degree) Burn	1	1
Cough	1	1
Respiratory Arrest	1	1
Respiratory Insufficiency	1	1
Patient Problem/Medical Problem	1	1