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
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	3
DRAEGERWERK AG & CO KGAA
	SUBSTANTIALLY EQUIVALENT	1
1. K221118 CO2 Mainstream Sensor
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	1
INVENTEUR, LLC
	SUBSTANTIALLY EQUIVALENT	1
MASIMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PNEUMA THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRIOR CARE SCIENCE TECHNOLOGY, LTD.
	SUBSTANTIALLY EQUIVALENT	1
SOUTHMEDIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
UNIMED MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Communication or Transmission Problem	3145	3145
Break	2979	2979
Crack	1878	1878
Corroded	1053	1054
Device Alarm System	782	782
Failure to Calibrate	778	778
Calibration Problem	573	574
Computer Software Problem	472	472
Appropriate Term/Code Not Available	469	489
Loose or Intermittent Connection	381	381
Incorrect, Inadequate or Imprecise Result or Readings	373	373
No Apparent Adverse Event	285	285
No Device Output	265	265
Insufficient Information	240	240
Circuit Failure	228	228
Output Problem	164	164
Contamination	162	162
Unable to Obtain Readings	126	126
Missing Information	125	125
Physical Resistance/Sticking	110	110
Device Sensing Problem	106	106
Failure of Device to Self-Test	85	86
Display or Visual Feedback Problem	74	74
Inadequate or Insufficient Training	65	65
Display Difficult to Read	64	64
Incorrect Measurement	63	63
Low Readings	56	56
High Readings	51	51
Failure to Read Input Signal	51	51
Image Display Error/Artifact	48	48
Gas Output Problem	37	37
Misassembled	36	36
Peeled/Delaminated	32	32
Pumping Stopped	32	32
Application Program Problem	30	30
Failure to Power Up	29	29
Degraded	27	27
Electrical /Electronic Property Problem	20	20
No Display/Image	20	20
Failure to Cycle	18	18
Temperature Problem	18	18
Mechanical Problem	17	17
Application Program Freezes, Becomes Nonfunctional	16	16
Device Markings/Labelling Problem	16	16
Failure to Analyze Signal	15	15
Unexpected Shutdown	15	15
Defective Component	14	14
Noise, Audible	14	14
Pumping Problem	14	14
Data Problem	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8421	8443
No Patient Involvement	790	790
Insufficient Information	139	141
No Information	38	38
No Consequences Or Impact To Patient	27	27
Unintended Extubation	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Cardiac Arrest	5	5
Low Oxygen Saturation	5	5
Unspecified Tissue Injury	4	4
Laceration(s)	2	2
Respiratory Failure	2	2
Superficial (First Degree) Burn	1	1
Hypoventilation	1	1
Respiratory Arrest	1	1
Burn(s)	1	1
Foreign Body In Patient	1	1
Discomfort	1	1
Pain	1	1
Eye Injury	1	1
Anxiety	1	1
Cough	1	1
Hypoxia	1	1
Bacterial Infection	1	1
Respiratory Insufficiency	1	1
Bruise/Contusion	1	1
Lethargy	1	1