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	3513	3513
Communication or Transmission Problem	3145	3145
Crack	2668	2668
Corroded	1095	1096
Failure to Calibrate	1043	1043
Appropriate Term/Code Not Available	946	966
Device Alarm System	757	757
Incorrect, Inadequate or Imprecise Result or Readings	743	743
Computer Software Problem	564	564
Contamination	537	537
No Device Output	501	501
Failure of Device to Self-Test	496	497
Calibration Problem	495	496
Loose or Intermittent Connection	447	447
No Apparent Adverse Event	424	424
Circuit Failure	308	308
Insufficient Information	295	295
Output Problem	255	255
Device Sensing Problem	181	181
Unable to Obtain Readings	139	139
Physical Resistance/Sticking	138	138
Missing Information	125	125
Failure to Read Input Signal	111	111
Display or Visual Feedback Problem	104	104
Display Difficult to Read	78	78
Incorrect Measurement	69	69
Application Program Freezes, Becomes Nonfunctional	62	62
Low Readings	54	54
Misassembled	50	50
High Readings	46	46
Failure to Power Up	40	40
Gas Output Problem	40	40
Image Display Error/Artifact	39	39
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
Inadequate or Insufficient Training	24	24
Power Problem	24	24
No Display/Image	22	22
Temperature Problem	22	22
Mechanical Problem	21	21
Noise, Audible	17	17
Device Markings/Labelling Problem	17	17
Erratic or Intermittent Display	15	15
Failure to Analyze Signal	14	14
Unexpected Shutdown	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8013	8035
No Patient Involvement	2990	2990
Insufficient Information	135	137
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
Pain	2	2
Hypoxia	2	2
Respiratory Failure	2	2
Cyanosis	1	1
Patient Problem/Medical Problem	1	1
Superficial (First Degree) Burn	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
Laceration(s)	1	1
Anxiety	1	1
Cough	1	1
Pressure Sores	1	1
Inadequate Pain Relief	1	1
Extubate	1	1
Respiratory Insufficiency	1	1
Bacterial Infection	1	1
Lethargy	1	1
Bruise/Contusion	1	1