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
1. K192446 CO2 Mainstream Module
2. K192488 CO2 Sidestream Module
BLUEPOINT MEDICAL GMBH & CO. KG
	SUBSTANTIALLY EQUIVALENT	1
CMI HEALTH, INC.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	3
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
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	3537	3537
Communication or Transmission Problem	3368	3368
Crack	2685	2685
Corroded	1105	1106
Failure to Calibrate	1102	1102
Appropriate Device Problem Term/Code Not Available	930	930
Device Alarm System	865	865
Incorrect, Inadequate or Imprecise Result or Readings	765	765
Calibration Problem	687	688
Computer Software Problem	556	556
No Device Output	551	551
Contamination	538	538
Failure of Device to Self-Test	505	506
Loose or Intermittent Connection	464	464
No Apparent Adverse Event	426	426
Circuit Failure	310	310
Insufficient Device Problem Information	282	282
Output Problem	280	280
Device Sensing Problem	176	176
Unable to Obtain Readings	148	148
Physical Resistance/Sticking	139	139
Missing Information	125	125
Display or Visual Feedback Problem	114	114
Failure to Read Input Signal	107	107
Display Difficult to Read	78	78
Incorrect Measurement	75	75
Low Readings	71	71
Inadequate or Insufficient Training	70	70
Application Program Freezes or Fails to Launch	62	62
Gas Output Problem	56	56
High Readings	55	55
Image Display Error/Artifact	52	52
Misassembled	51	51
Pumping Stopped	40	40
Failure to Power Up	40	40
Peeled/Delaminated	38	38
Application Program Problem	33	33
Electrical /Electronic Property Problem	29	29
Naturally Worn	27	27
Degraded	27	27
Failure to Cycle	24	24
No Display/Image	24	24
Power Problem	24	24
Temperature Problem	23	23
Mechanical Problem	21	21
Failure to Analyze Signal	18	18
Noise, Audible	18	18
Use of Device Problem	16	17
Unexpected Shutdown	16	16
Device Markings/Labelling Problem	16	16

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8756	8778
No Patient Involvement	2990	2990
Insufficient Information	152	154
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 and Conditions Term/Code Not Available	9	9
Low Oxygen Saturation	6	6
Cardiac Arrest	5	5
Unspecified Tissue Injury	4	4
Foreign Body In Patient	3	3
Hypoxia	2	2
Respiratory Distress	2	2
Pain	2	2
Death	2	2
Respiratory Failure	2	2
Laceration(s)	2	2
Perforation	1	1
Cyanosis	1	1
Patient Problem/Medical Problem	1	1
Lethargy	1	1
Discomfort	1	1
Respiratory Arrest	1	1
Hypoventilation	1	1
Eye Injury	1	1
Pressure Sore/Ulcer	1	1
Extubate	1	1
Inadequate Pain Relief	1	1
Superficial (First Degree) Burn	1	1
Injury	1	1
Burn(s)	1	1
Hypersensitivity/Allergic reaction	1	1
Anxiety	1	1
Cardiopulmonary Arrest	1	1
Cough	1	1
Bruise/Contusion	1	1
Chest Pain	1	1
Respiratory Insufficiency	1	1
Bacterial Infection	1	1