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
1. K221118 CO2 Mainstream Sensor
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
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	3417	3417
Communication or Transmission Problem	2791	2791
Crack	2432	2432
Corroded	1022	1022
Failure to Calibrate	950	950
Appropriate Term/Code Not Available	945	945
Incorrect, Inadequate or Imprecise Result or Readings	738	738
Device Alarm System	664	664
Computer Software Problem	564	564
Contamination	530	530
Failure of Device to Self-Test	486	486
No Device Output	482	482
Loose or Intermittent Connection	430	430
No Apparent Adverse Event	416	416
Calibration Problem	410	410
Circuit Failure	302	302
Insufficient Information	295	295
Output Problem	225	225
Device Sensing Problem	185	185
Physical Resistance/Sticking	126	126
Failure to Read Input Signal	110	110
Display or Visual Feedback Problem	83	83
Display Difficult to Read	77	77
Missing Information	68	68
Incorrect Measurement	64	64
Application Program Freezes, Becomes Nonfunctional	62	62
Unable to Obtain Readings	60	60
Low Readings	50	50
Misassembled	50	50
High Readings	41	41
Failure to Power Up	39	39
Peeled/Delaminated	38	38
Pumping Stopped	37	37
Application Program Problem	29	29
Degraded	28	28
Naturally Worn	28	28
Failure to Cycle	25	25
Electrical /Electronic Property Problem	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
Noise, Audible	14	14
Erratic or Intermittent Display	14	14
Unexpected Shutdown	13	13
Use of Device Problem	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7133	7133
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
Cardiac Arrest	5	5
Low Oxygen Saturation	5	5
Unspecified Tissue Injury	4	4
Foreign Body In Patient	3	3
Hypoxia	3	3
Death	2	2
Respiratory Distress	2	2
Pain	2	2
Respiratory Failure	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