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
1. K220533 Endoscopy Oxygen Mask
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	3
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	3445	3445
Communication or Transmission Problem	2951	2951
Crack	2496	2496
Corroded	1049	1049
Failure to Calibrate	964	964
Appropriate Term/Code Not Available	945	945
Incorrect, Inadequate or Imprecise Result or Readings	742	742
Device Alarm System	693	693
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	423	423
No Apparent Adverse Event	417	417
Circuit Failure	304	304
Insufficient Information	295	295
Output Problem	232	232
Device Sensing Problem	185	185
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	71	71
Incorrect Measurement	68	68
Application Program Freezes, Becomes Nonfunctional	62	62
Low Readings	52	52
Misassembled	50	50
High Readings	42	42
Failure to Power Up	39	39
Pumping Stopped	38	38
Peeled/Delaminated	38	38
Application Program Problem	30	30
Naturally Worn	28	28
Degraded	28	28
Gas Output Problem	27	27
Electrical /Electronic Property Problem	25	25
Failure to Cycle	25	25
Power Problem	23	23
Image Display Error/Artifact	22	22
Temperature Problem	22	22
Mechanical Problem	19	19
No Display/Image	18	18
Device Operates Differently Than Expected	16	16
Device Markings/Labelling Problem	15	15
Erratic or Intermittent Display	14	14
Unexpected Shutdown	14	14
Noise, Audible	14	14
Use of Device Problem	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7435	7435
No Patient Involvement	3000	3000
No Known Impact Or Consequence To Patient	146	146
No Consequences Or Impact To Patient	143	143
Insufficient Information	134	134
No Information	88	88
Unintended Extubation	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
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
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
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
Death, Intrauterine Fetal	1	1
Lethargy	1	1
Bruise/Contusion	1	1