TPLC - Total Product Life Cycle

show TPLC since

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
CMI HEALTH INC.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN LLC
	SUBSTANTIALLY EQUIVALENT	2
DRAEGERWERK AG & CO. KGAA
	SUBSTANTIALLY EQUIVALENT	1
1. K221118 CO2 Mainstream Sensor
ENDURE INDUSTRIES INC
	SUBSTANTIALLY EQUIVALENT	1
ENGINEERED MEDICAL SYSTEMS INC.
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE FINLAND OY
	SUBSTANTIALLY EQUIVALENT	3
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	2
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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3286	3286
Communication or Transmission Problem	2408	2408
Crack	2274	2274
Appropriate Term/Code Not Available	944	944
Corroded	927	927
Failure to Calibrate	852	852
Incorrect, Inadequate or Imprecise Result or Readings	735	735
Computer Software Problem	564	564
Device Alarm System	562	562
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	356	356
Circuit Failure	299	299
Insufficient Information	295	295
Output Problem	220	220
Device Sensing Problem	184	184
Physical Resistance/Sticking	116	116
Failure to Read Input Signal	108	108
Display Difficult to Read	77	77
Display or Visual Feedback Problem	74	74
Application Program Freezes, Becomes Nonfunctional	61	61
Unable to Obtain Readings	57	57
Misassembled	49	49
Incorrect Measurement	43	43
Pumping Stopped	37	37
Peeled/Delaminated	37	37
Failure to Power Up	37	37
Low Readings	33	33
High Readings	32	32
Naturally Worn	28	28
Degraded	27	27
Application Program Problem	26	26
Failure to Cycle	25	25
Electrical /Electronic Property Problem	24	24
Power Problem	22	22
Gas Output Problem	20	20
Mechanical Problem	19	19
Temperature Problem	18	18
Missing Information	17	17
Image Display Error/Artifact	17	17
Device Operates Differently Than Expected	16	16
No Display/Image	16	16
Device Markings/Labelling Problem	15	15
Erratic or Intermittent Display	14	14
Device Displays Incorrect Message	13	13
Unexpected Shutdown	13	13
Noise, Audible	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6363	6363
No Patient Involvement	3000	3000
No Known Impact Or Consequence To Patient	146	146
No Consequences Or Impact To Patient	143	143
Insufficient Information	111	111
No Information	88	88
Unintended Extubation	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Unspecified Tissue Injury	4	4
Low Oxygen Saturation	4	4
Cardiac Arrest	3	3
Foreign Body In Patient	3	3
Hypoxia	3	3
Death	2	2
Respiratory Distress	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
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
Pain	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