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
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	3
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. A.S.
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
1. K161860 TG-970P CO2 Sensor Kit
2. K171765 Nihon Kohden CO2 Monitor
ORANTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
ORIDION MEDICAL 1987 LTD.
	SUBSTANTIALLY EQUIVALENT	3
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH
	SUBSTANTIALLY EQUIVALENT	1
PNEUMA THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
POM MEDICAL, LLC
	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
VENTURE THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3411	3411
Communication or Transmission Problem	2755	2755
Crack	2415	2415
Corroded	1010	1010
Appropriate Term/Code Not Available	945	945
Failure to Calibrate	935	935
Incorrect, Inadequate or Imprecise Result or Readings	738	738
Device Alarm System	651	651
Computer Software Problem	564	564
Contamination	530	530
Failure of Device to Self-Test	486	486
No Device Output	478	478
Loose or Intermittent Connection	424	424
No Apparent Adverse Event	416	416
Calibration Problem	399	399
Circuit Failure	302	302
Insufficient Information	295	295
Output Problem	222	222
Device Sensing Problem	185	185
Physical Resistance/Sticking	126	126
Failure to Read Input Signal	110	110
Display Difficult to Read	77	77
Display or Visual Feedback Problem	75	75
Application Program Freezes, Becomes Nonfunctional	62	62
Incorrect Measurement	62	62
Unable to Obtain Readings	59	59
Missing Information	53	53
Misassembled	50	50
Low Readings	48	48
High Readings	40	40
Failure to Power Up	39	39
Peeled/Delaminated	38	38
Pumping Stopped	37	37
Application Program Problem	29	29
Naturally Worn	28	28
Degraded	28	28
Electrical /Electronic Property Problem	25	25
Failure to Cycle	25	25
Power Problem	22	22
Temperature Problem	22	22
Gas Output Problem	21	21
Image Display Error/Artifact	19	19
Mechanical Problem	19	19
No Display/Image	17	17
Device Operates Differently Than Expected	16	16
Device Markings/Labelling Problem	15	15
Erratic or Intermittent Display	14	14
Use of Device Problem	13	13
Unexpected Shutdown	13	13
Device Displays Incorrect Message	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7018	7018
No Patient Involvement	3000	3000
No Known Impact Or Consequence To Patient	146	146
No Consequences Or Impact To Patient	143	143
Insufficient Information	129	129
No Information	88	88
Unintended Extubation	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Low Oxygen Saturation	5	5
Cardiac Arrest	4	4
Unspecified Tissue Injury	4	4
Foreign Body In Patient	3	3
Hypoxia	3	3
Death	2	2
Respiratory Distress	2	2
Pain	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
Burn, Thermal	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
Partial thickness (Second Degree) Burn	1	1
Pressure Sores	1	1
Inadequate Pain Relief	1	1
Extubate	1	1
Respiratory Insufficiency	1	1
Bruise/Contusion	1	1
Death, Intrauterine Fetal	1	1
Lethargy	1	1