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
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
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	3411	3411
Communication or Transmission Problem	2790	2790
Crack	2430	2430
Corroded	1022	1022
Failure to Calibrate	948	948
Appropriate Term/Code Not Available	942	942
Incorrect, Inadequate or Imprecise Result or Readings	710	710
Device Alarm System	659	659
Computer Software Problem	562	562
Contamination	530	530
Failure of Device to Self-Test	486	486
No Device Output	470	470
Loose or Intermittent Connection	429	429
No Apparent Adverse Event	416	416
Calibration Problem	393	393
Circuit Failure	300	300
Insufficient Information	294	294
Device Sensing Problem	175	175
Output Problem	166	166
Physical Resistance/Sticking	126	126
Failure to Read Input Signal	109	109
Missing Information	68	68
Display Difficult to Read	68	68
Display or Visual Feedback Problem	67	67
Application Program Freezes, Becomes Nonfunctional	62	62
Incorrect Measurement	56	56
Misassembled	49	49
Low Readings	44	44
Unable to Obtain Readings	44	44
High Readings	39	39
Peeled/Delaminated	38	38
Pumping Stopped	36	36
Failure to Power Up	31	31
Degraded	28	28
Application Program Problem	28	28
Naturally Worn	26	26
Failure to Cycle	23	23
Electrical /Electronic Property Problem	23	23
Temperature Problem	21	21
Image Display Error/Artifact	18	18
Device Markings/Labelling Problem	15	15
No Display/Image	15	15
Mechanical Problem	13	13
False Alarm	12	12
Erratic or Intermittent Display	12	12
Power Problem	12	12
Noise, Audible	11	11
Device Ingredient or Reagent Problem	11	11
Unexpected Shutdown	11	11
Use of Device Problem	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	7118	7118
No Patient Involvement	2965	2965
Insufficient Information	129	129
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	8	8
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
Bruise/Contusion	1	1
Lethargy	1	1