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
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	1
INVENTEUR, LLC
	SUBSTANTIALLY EQUIVALENT	1
MASIMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDITERA TIBBI MALZEME SAN. VE TIC. A.S.
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
ORIDION MEDICAL 1987 LTD.
	SUBSTANTIALLY EQUIVALENT	1
PNEUMA THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOUTHMEDIC INC.
	SUBSTANTIALLY EQUIVALENT	1
UNIMED MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3439	3439
Communication or Transmission Problem	2950	2950
Crack	2494	2494
Corroded	1049	1049
Failure to Calibrate	962	962
Appropriate Term/Code Not Available	942	942
Incorrect, Inadequate or Imprecise Result or Readings	714	714
Device Alarm System	688	688
Computer Software Problem	562	562
Contamination	530	530
Failure of Device to Self-Test	490	490
No Device Output	474	474
Loose or Intermittent Connection	440	440
No Apparent Adverse Event	417	417
Calibration Problem	406	406
Circuit Failure	302	302
Insufficient Information	294	294
Device Sensing Problem	175	175
Output Problem	173	173
Physical Resistance/Sticking	126	126
Missing Information	117	117
Failure to Read Input Signal	109	109
Display or Visual Feedback Problem	69	69
Display Difficult to Read	69	69
Application Program Freezes, Becomes Nonfunctional	62	62
Incorrect Measurement	60	60
Unable to Obtain Readings	55	55
Misassembled	49	49
Low Readings	46	46
High Readings	40	40
Peeled/Delaminated	38	38
Pumping Stopped	37	37
Failure to Power Up	31	31
Application Program Problem	29	29
Degraded	28	28
Naturally Worn	26	26
Failure to Cycle	23	23
Electrical /Electronic Property Problem	23	23
Image Display Error/Artifact	21	21
Temperature Problem	21	21
No Display/Image	16	16
Device Markings/Labelling Problem	15	15
Gas Output Problem	15	15
Power Problem	13	13
Mechanical Problem	13	13
Erratic or Intermittent Display	12	12
Unexpected Shutdown	12	12
False Alarm	12	12
Defective Component	12	12
Obstruction of Flow	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7420	7420
No Patient Involvement	2965	2965
Insufficient Information	134	134
No Consequences Or Impact To Patient	78	78
No Information	55	55
No Known Impact Or Consequence To Patient	25	25
Unintended Extubation	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9
Cardiac Arrest	5	5
Unspecified Tissue Injury	4	4
Low Oxygen Saturation	2	2
Respiratory Failure	2	2
Superficial (First Degree) Burn	1	1
Death	1	1
Hypoventilation	1	1
Respiratory Arrest	1	1
Foreign Body In Patient	1	1
Chest Pain	1	1
Discomfort	1	1
Laceration(s)	1	1
Pain	1	1
Anxiety	1	1
Cough	1	1
Hypoxia	1	1
Extubate	1	1
Respiratory Insufficiency	1	1
Lethargy	1	1
Bruise/Contusion	1	1