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	2
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
1. K212425 MicroTrend System
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	3103	3103
Break	2974	2974
Crack	1878	1878
Corroded	1053	1054
Failure to Calibrate	767	767
Device Alarm System	764	764
Calibration Problem	557	558
Computer Software Problem	472	472
Appropriate Term/Code Not Available	469	489
Loose or Intermittent Connection	379	379
Incorrect, Inadequate or Imprecise Result or Readings	359	359
No Apparent Adverse Event	282	282
No Device Output	264	264
Insufficient Information	240	240
Circuit Failure	227	227
Contamination	162	162
Output Problem	159	159
Missing Information	125	125
Unable to Obtain Readings	125	125
Physical Resistance/Sticking	110	110
Device Sensing Problem	106	106
Failure of Device to Self-Test	84	85
Display or Visual Feedback Problem	72	72
Display Difficult to Read	64	64
Incorrect Measurement	62	62
Inadequate or Insufficient Training	56	56
Low Readings	56	56
Failure to Read Input Signal	51	51
High Readings	49	49
Image Display Error/Artifact	46	46
Misassembled	36	36
Gas Output Problem	35	35
Peeled/Delaminated	32	32
Pumping Stopped	32	32
Application Program Problem	30	30
Failure to Power Up	29	29
Degraded	27	27
No Display/Image	19	19
Electrical /Electronic Property Problem	19	19
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
Pumping Problem	14	14
Noise, Audible	14	14
Data Problem	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8308	8330
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
Unspecified Tissue Injury	4	4
Low Oxygen Saturation	3	3
Laceration(s)	2	2
Respiratory Failure	2	2
Superficial (First Degree) Burn	1	1
Hypoventilation	1	1
Respiratory Arrest	1	1
Foreign Body In Patient	1	1
Discomfort	1	1
Pain	1	1
Anxiety	1	1
Cough	1	1
Hypoxia	1	1
Respiratory Insufficiency	1	1
Bacterial Infection	1	1
Lethargy	1	1
Bruise/Contusion	1	1