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
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	3517	3517
Communication or Transmission Problem	3191	3191
Crack	2683	2683
Corroded	1097	1098
Failure to Calibrate	1047	1047
Appropriate Term/Code Not Available	946	966
Device Alarm System	771	771
Incorrect, Inadequate or Imprecise Result or Readings	746	746
Computer Software Problem	565	565
Contamination	537	537
Calibration Problem	519	520
No Device Output	508	508
Failure of Device to Self-Test	496	497
Loose or Intermittent Connection	454	454
No Apparent Adverse Event	424	424
Circuit Failure	312	312
Insufficient Information	295	295
Output Problem	264	264
Device Sensing Problem	181	181
Unable to Obtain Readings	143	143
Physical Resistance/Sticking	138	138
Missing Information	125	125
Failure to Read Input Signal	111	111
Display or Visual Feedback Problem	107	107
Display Difficult to Read	78	78
Incorrect Measurement	69	69
Application Program Freezes, Becomes Nonfunctional	62	62
Low Readings	57	57
Misassembled	50	50
High Readings	47	47
Gas Output Problem	45	45
Image Display Error/Artifact	43	43
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
Inadequate or Insufficient Training	27	27
Electrical /Electronic Property Problem	26	26
Failure to Cycle	25	25
Power Problem	24	24
No Display/Image	22	22
Temperature Problem	22	22
Mechanical Problem	21	21
Noise, Audible	17	17
Unexpected Shutdown	17	17
Device Markings/Labelling Problem	17	17
Defective Component	15	15
Failure to Analyze Signal	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8131	8153
No Patient Involvement	2990	2990
Insufficient Information	136	138
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
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
Injury	1	1
Chest Pain	1	1
Discomfort	1	1
Cardiopulmonary Arrest	1	1
Anxiety	1	1
Cough	1	1
Bacterial Infection	1	1
Pressure Sores	1	1
Inadequate Pain Relief	1	1
Extubate	1	1
Respiratory Insufficiency	1	1
Bruise/Contusion	1	1
Lethargy	1	1