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
BEIJING KINGST COMMERCIAL & TRADE CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	2
1. K192446 CO2 Mainstream Module
2. K192488 CO2 Sidestream Module
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	2
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	1
ORANTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
ORIDION MEDICAL 1987 LTD.
	SUBSTANTIALLY EQUIVALENT	3
PNEUMA THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
POM MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
PRIOR CARE SCIENCE TECHNOLOGY LTD
	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
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3500	3500
Communication or Transmission Problem	3117	3117
Crack	2644	2644
Corroded	1092	1092
Failure to Calibrate	1023	1023
Appropriate Term/Code Not Available	946	966
Device Alarm System	748	748
Incorrect, Inadequate or Imprecise Result or Readings	743	743
Computer Software Problem	564	564
Contamination	537	537
No Device Output	500	500
Failure of Device to Self-Test	496	496
Calibration Problem	466	466
Loose or Intermittent Connection	444	444
No Apparent Adverse Event	422	422
Circuit Failure	308	308
Insufficient Information	295	295
Output Problem	250	250
Device Sensing Problem	181	181
Physical Resistance/Sticking	138	138
Unable to Obtain Readings	134	134
Missing Information	124	124
Failure to Read Input Signal	111	111
Display or Visual Feedback Problem	101	101
Display Difficult to Read	78	78
Incorrect Measurement	69	69
Application Program Freezes, Becomes Nonfunctional	62	62
Low Readings	53	53
Misassembled	50	50
High Readings	43	43
Failure to Power Up	40	40
Pumping Stopped	39	39
Peeled/Delaminated	38	38
Gas Output Problem	37	37
Image Display Error/Artifact	35	35
Application Program Problem	32	32
Degraded	28	28
Naturally Worn	28	28
Failure to Cycle	25	25
Electrical /Electronic Property Problem	25	25
Power Problem	24	24
No Display/Image	22	22
Temperature Problem	22	22
Mechanical Problem	21	21
Inadequate or Insufficient Training	18	18
Noise, Audible	17	17
Device Markings/Labelling Problem	15	15
Erratic or Intermittent Display	15	15
Failure to Analyze Signal	14	14
Unexpected Shutdown	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7919	7939
No Patient Involvement	2990	2990
Insufficient Information	133	133
No Consequences Or Impact To Patient	132	132
No Known Impact Or Consequence To Patient	114	114
No Information	81	81
Unintended Extubation	15	15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Cardiac Arrest	5	5
Unspecified Tissue Injury	4	4
Low Oxygen Saturation	4	4
Foreign Body In Patient	3	3
Death	2	2
Respiratory Distress	2	2
Pain	2	2
Hypoxia	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
Injury	1	1
Chest Pain	1	1
Discomfort	1	1
Cardiopulmonary Arrest	1	1
Laceration(s)	1	1
Anxiety	1	1
Cough	1	1
Pressure Sores	1	1
Inadequate Pain Relief	1	1
Extubate	1	1
Respiratory Insufficiency	1	1
Bruise/Contusion	1	1
Lethargy	1	1