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
1. K203762 Nellcor EASYCAP II Adult Colorimetric CO2 Detector ...
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	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	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3330	3330
Communication or Transmission Problem	2518	2518
Crack	2316	2316
Corroded	951	951
Appropriate Term/Code Not Available	944	944
Failure to Calibrate	880	880
Incorrect, Inadequate or Imprecise Result or Readings	737	737
Device Alarm System	620	620
Computer Software Problem	564	564
Contamination	522	522
Failure of Device to Self-Test	475	475
No Device Output	466	466
No Apparent Adverse Event	412	412
Loose or Intermittent Connection	408	408
Calibration Problem	375	375
Circuit Failure	300	300
Insufficient Information	295	295
Output Problem	220	220
Device Sensing Problem	184	184
Physical Resistance/Sticking	118	118
Failure to Read Input Signal	109	109
Display Difficult to Read	77	77
Display or Visual Feedback Problem	74	74
Application Program Freezes, Becomes Nonfunctional	62	62
Unable to Obtain Readings	58	58
Incorrect Measurement	50	50
Misassembled	49	49
Failure to Power Up	39	39
Peeled/Delaminated	38	38
Pumping Stopped	37	37
High Readings	35	35
Low Readings	34	34
Missing Information	31	31
Degraded	28	28
Naturally Worn	28	28
Application Program Problem	26	26
Failure to Cycle	25	25
Electrical /Electronic Property Problem	24	24
Power Problem	22	22
Temperature Problem	21	21
Gas Output Problem	20	20
Image Display Error/Artifact	19	19
Mechanical Problem	19	19
No Display/Image	17	17
Device Operates Differently Than Expected	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	6613	6613
No Patient Involvement	3000	3000
No Known Impact Or Consequence To Patient	146	146
No Consequences Or Impact To Patient	143	143
Insufficient Information	121	121
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
Hypoventilation	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