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
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
1. K172365 Panoramic Oxygen Mask (POM)
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	3444	3444
Communication or Transmission Problem	2951	2951
Crack	2496	2496
Corroded	1049	1049
Failure to Calibrate	963	963
Appropriate Term/Code Not Available	945	945
Incorrect, Inadequate or Imprecise Result or Readings	738	738
Device Alarm System	691	691
Computer Software Problem	564	564
Contamination	530	530
Failure of Device to Self-Test	490	490
No Device Output	486	486
Loose or Intermittent Connection	441	441
Calibration Problem	419	419
No Apparent Adverse Event	417	417
Circuit Failure	304	304
Insufficient Information	295	295
Output Problem	230	230
Device Sensing Problem	181	181
Physical Resistance/Sticking	126	126
Missing Information	117	117
Failure to Read Input Signal	110	110
Display or Visual Feedback Problem	85	85
Display Difficult to Read	78	78
Unable to Obtain Readings	69	69
Incorrect Measurement	67	67
Application Program Freezes, Becomes Nonfunctional	62	62
Low Readings	52	52
Misassembled	49	49
High Readings	42	42
Failure to Power Up	39	39
Peeled/Delaminated	38	38
Pumping Stopped	38	38
Application Program Problem	30	30
Naturally Worn	28	28
Degraded	28	28
Gas Output Problem	27	27
Failure to Cycle	25	25
Electrical /Electronic Property Problem	25	25
Power Problem	23	23
Image Display Error/Artifact	22	22
Temperature Problem	21	21
No Display/Image	18	18
Mechanical Problem	18	18
Device Markings/Labelling Problem	15	15
Noise, Audible	14	14
Unexpected Shutdown	14	14
Erratic or Intermittent Display	14	14
Defective Component	13	13
False Alarm	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7433	7433
No Patient Involvement	2990	2990
Insufficient Information	134	134
No Consequences Or Impact To Patient	132	132
No Known Impact Or Consequence To Patient	114	114
No Information	81	81
Unintended Extubation	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Cardiac Arrest	5	5
Unspecified Tissue Injury	4	4
Foreign Body In Patient	3	3
Low Oxygen Saturation	3	3
Death	2	2
Respiratory Distress	2	2
Pain	2	2
Hypoxia	2	2
Respiratory Failure	2	2
Cyanosis	1	1
Patient Problem/Medical Problem	1	1
Superficial (First Degree) Burn	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
Lethargy	1	1
Bruise/Contusion	1	1