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
AFFIRM MEDICAL TECHNOLOGIES II, LLC
	SUBSTANTIALLY EQUIVALENT	1
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	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	2
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	3545	3545
Communication or Transmission Problem	3428	3428
Crack	2688	2688
Failure to Calibrate	1121	1121
Corroded	1110	1111
Device Alarm System	931	931
Appropriate Device Problem Term/Code Not Available	930	930
Incorrect, Inadequate or Imprecise Result or Readings	773	773
Calibration Problem	728	729
No Device Output	563	563
Computer Software Problem	556	556
Contamination	538	538
Failure of Device to Self-Test	517	518
Loose or Intermittent Connection	465	465
No Apparent Adverse Event	426	426
Circuit Failure	311	311
Output Problem	292	292
Insufficient Device Problem Information	282	282
Device Sensing Problem	176	176
Unable to Obtain Readings	153	153
Physical Resistance/Sticking	140	140
Missing Information	125	125
Display or Visual Feedback Problem	115	115
Failure to Read Input Signal	107	107
Incorrect Measurement	84	84
Display Difficult to Read	79	79
Low Readings	75	75
Inadequate or Insufficient Training	72	72
Application Program Freezes or Fails to Launch	62	62
High Readings	56	56
Gas Output Problem	56	56
Image Display Error/Artifact	54	54
Misassembled	51	51
Pumping Stopped	42	42
Failure to Power Up	40	40
Peeled/Delaminated	38	38
Application Program Problem	33	33
Electrical /Electronic Property Problem	29	29
Naturally Worn	28	28
Degraded	27	27
Power Problem	25	25
No Display/Image	24	24
Failure to Cycle	24	24
Temperature Problem	23	23
Mechanical Problem	21	21
Failure to Analyze Signal	19	19
Unexpected Shutdown	18	18
Noise, Audible	18	18
Device Markings/Labelling Problem	16	16
Use of Device Problem	16	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8992	9014
No Patient Involvement	2990	2990
Insufficient Information	163	165
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	10	10
Low Oxygen Saturation	7	7
Cardiac Arrest	5	5
Unspecified Tissue Injury	4	4
Foreign Body In Patient	3	3
Death	2	2
Respiratory Distress	2	2
Laceration(s)	2	2
Pain	2	2
Hypoxia	2	2
Respiratory Failure	2	2
Cyanosis	1	1
Superficial (First Degree) Burn	1	1
Patient Problem/Medical Problem	1	1
Hypersensitivity/Allergic reaction	1	1
Hypoventilation	1	1
Respiratory Arrest	1	1
Perforation	1	1
Burn(s)	1	1
Injury	1	1
Chest Pain	1	1
Discomfort	1	1
Cardiopulmonary Arrest	1	1
Pressure Sore/Ulcer	1	1
Eye Injury	1	1
Anxiety	1	1
Cough	1	1
Bacterial Infection	1	1
Inadequate Pain Relief	1	1
Extubate	1	1
Respiratory Insufficiency	1	1
Bruise/Contusion	1	1
Lethargy	1	1