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
BLUEPOINT MEDICAL GMBH & CO. KG
	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
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
ORIDION MEDICAL 1987 LTD.
	SUBSTANTIALLY EQUIVALENT	3
PNEUMA THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SOUTHMEDIC INC.
	SUBSTANTIALLY EQUIVALENT	1
TYLENOL MEDICAL INSTRUMENTS CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
UNIMED MEDICAL SUPPLIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3284	3284
Communication or Transmission Problem	2408	2408
Crack	2274	2274
Appropriate Term/Code Not Available	944	944
Corroded	927	927
Failure to Calibrate	851	851
Incorrect, Inadequate or Imprecise Result or Readings	719	719
Computer Software Problem	564	564
Device Alarm System	560	560
Contamination	509	509
Failure of Device to Self-Test	474	474
No Device Output	463	463
No Apparent Adverse Event	409	409
Loose or Intermittent Connection	400	400
Calibration Problem	348	348
Circuit Failure	299	299
Insufficient Information	294	294
Output Problem	204	204
Device Sensing Problem	176	176
Physical Resistance/Sticking	116	116
Failure to Read Input Signal	108	108
Display Difficult to Read	76	76
Display or Visual Feedback Problem	72	72
Application Program Freezes, Becomes Nonfunctional	61	61
Unable to Obtain Readings	50	50
Misassembled	48	48
Failure to Power Up	37	37
Peeled/Delaminated	37	37
Pumping Stopped	37	37
Incorrect Measurement	36	36
Low Readings	31	31
High Readings	31	31
Degraded	27	27
Naturally Worn	27	27
Application Program Problem	26	26
Failure to Cycle	25	25
Electrical /Electronic Property Problem	23	23
Power Problem	22	22
Gas Output Problem	19	19
Temperature Problem	17	17
Missing Information	17	17
Image Display Error/Artifact	17	17
Device Markings/Labelling Problem	15	15
No Display/Image	15	15
Mechanical Problem	15	15
Erratic or Intermittent Display	14	14
Noise, Audible	12	12
False Alarm	12	12
Unexpected Shutdown	12	12
Device Ingredient or Reagent Problem	10	10

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6361	6361
No Patient Involvement	2984	2984
No Consequences Or Impact To Patient	117	117
Insufficient Information	111	111
No Information	81	81
No Known Impact Or Consequence To Patient	76	76
Unintended Extubation	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Unspecified Tissue Injury	4	4
Cardiac Arrest	3	3
Death	2	2
Foreign Body In Patient	2	2
Hypoxia	2	2
Cyanosis	1	1
Superficial (First Degree) Burn	1	1
Patient Problem/Medical Problem	1	1
Hypersensitivity/Allergic reaction	1	1
Respiratory Arrest	1	1
Chest Pain	1	1
Discomfort	1	1
Cardiopulmonary Arrest	1	1
Laceration(s)	1	1
Pain	1	1
Anxiety	1	1
Cough	1	1
Inadequate Pain Relief	1	1
Extubate	1	1
Respiratory Insufficiency	1	1
Low Oxygen Saturation	1	1
Lethargy	1	1