TPLC - Total Product Life Cycle

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Device	analyzer, gas, carbon-dioxide, gaseous-phase
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	3373	3373
Communication or Transmission Problem	2683	2683
Crack	2368	2368
Corroded	1002	1002
Appropriate Term/Code Not Available	941	941
Failure to Calibrate	916	916
Incorrect, Inadequate or Imprecise Result or Readings	709	709
Device Alarm System	632	632
Computer Software Problem	562	562
Contamination	528	528
Failure of Device to Self-Test	485	485
No Device Output	460	460
Loose or Intermittent Connection	418	418
No Apparent Adverse Event	416	416
Calibration Problem	372	372
Circuit Failure	299	299
Insufficient Information	294	294
Device Sensing Problem	174	174
Output Problem	162	162
Physical Resistance/Sticking	125	125
Failure to Read Input Signal	108	108
Display Difficult to Read	68	68
Application Program Freezes, Becomes Nonfunctional	62	62
Display or Visual Feedback Problem	58	58
Incorrect Measurement	50	50
Misassembled	49	49
Unable to Obtain Readings	43	43
Low Readings	40	40
High Readings	38	38
Peeled/Delaminated	38	38
Missing Information	37	37
Pumping Stopped	36	36
Failure to Power Up	31	31
Degraded	28	28
Application Program Problem	27	27
Naturally Worn	26	26
Failure to Cycle	23	23
Electrical /Electronic Property Problem	22	22
Temperature Problem	20	20
Image Display Error/Artifact	18	18
Device Markings/Labelling Problem	15	15
No Display/Image	15	15
Mechanical Problem	13	13
Power Problem	12	12
Erratic or Intermittent Display	12	12
False Alarm	12	12
Device Ingredient or Reagent Problem	11	11
Unexpected Shutdown	11	11
Noise, Audible	10	10
Use of Device Problem	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6858	6858
No Patient Involvement	2965	2965
Insufficient Information	127	127
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	4	4
Unspecified Tissue Injury	4	4
Low Oxygen Saturation	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