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
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
1. K222511 Oxy2Pro
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	3066	3066
Break	2968	2968
Crack	1878	1878
Corroded	1052	1053
Failure to Calibrate	744	744
Device Alarm System	739	739
Calibration Problem	540	541
Computer Software Problem	471	471
Appropriate Term/Code Not Available	469	489
Loose or Intermittent Connection	377	377
Incorrect, Inadequate or Imprecise Result or Readings	358	358
No Apparent Adverse Event	281	281
No Device Output	247	247
Insufficient Information	238	238
Circuit Failure	227	227
Contamination	161	161
Output Problem	157	157
Missing Information	125	125
Unable to Obtain Readings	123	123
Physical Resistance/Sticking	109	109
Device Sensing Problem	106	106
Failure of Device to Self-Test	78	79
Display or Visual Feedback Problem	68	68
Display Difficult to Read	64	64
Incorrect Measurement	61	61
Low Readings	56	56
Failure to Read Input Signal	51	51
Inadequate or Insufficient Training	50	50
High Readings	46	46
Image Display Error/Artifact	42	42
Misassembled	36	36
Gas Output Problem	35	35
Pumping Stopped	32	32
Peeled/Delaminated	32	32
Application Program Problem	30	30
Failure to Power Up	29	29
Degraded	27	27
Electrical /Electronic Property Problem	19	19
No Display/Image	19	19
Failure to Cycle	18	18
Temperature Problem	18	18
Mechanical Problem	17	17
Device Markings/Labelling Problem	16	16
Application Program Freezes, Becomes Nonfunctional	16	16
Failure to Analyze Signal	15	15
Unexpected Shutdown	15	15
Pumping Problem	14	14
Defective Component	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	8199	8221
No Patient Involvement	790	790
Insufficient Information	138	140
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