TPLC - Total Product Life Cycle

show TPLC since

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
AFFIRM MEDICAL TECHNOLOGIES II, LLC
	SUBSTANTIALLY EQUIVALENT	1
BARBARAS DEVELOPMENT, INC.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	3
DRAEGERWERK AG & CO KGAA
	SUBSTANTIALLY EQUIVALENT	1
ENDURE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
ENGINEERED MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXOSTAT MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE FINLAND OY
	SUBSTANTIALLY EQUIVALENT	1
1. K211171 CARESCAPE Respiratory Modules E-sCO, E-sCOV, E-sCO ...
INVENTEUR, LLC
	SUBSTANTIALLY EQUIVALENT	1
MASIMO CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
PNEUMA THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRIOR CARE SCIENCE TECHNOLOGY, LTD.
	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
Communication or Transmission Problem	3267	3267
Break	2991	2991
Crack	1872	1872
Corroded	1057	1058
Device Alarm System	873	873
Failure to Calibrate	801	801
Calibration Problem	691	692
Computer Software Problem	464	464
Appropriate Device Problem Term/Code Not Available	453	453
Incorrect, Inadequate or Imprecise Result or Readings	383	383
Loose or Intermittent Connection	382	382
No Device Output	295	295
No Apparent Adverse Event	283	283
Insufficient Device Problem Information	226	226
Circuit Failure	225	225
Output Problem	178	178
Contamination	162	162
Unable to Obtain Readings	131	131
Missing Information	125	125
Physical Resistance/Sticking	111	111
Device Sensing Problem	102	102
Failure of Device to Self-Test	98	99
Incorrect Measurement	74	74
Display or Visual Feedback Problem	74	74
Inadequate or Insufficient Training	72	72
Low Readings	69	69
Display Difficult to Read	65	65
High Readings	54	54
Image Display Error/Artifact	50	50
Failure to Read Input Signal	47	47
Gas Output Problem	42	42
Misassembled	37	37
Pumping Stopped	35	35
Peeled/Delaminated	32	32
Application Program Problem	31	31
Failure to Power Up	29	29
Degraded	26	26
Electrical /Electronic Property Problem	22	22
No Display/Image	21	21
Temperature Problem	19	19
Failure to Analyze Signal	17	17
Unexpected Shutdown	17	17
Mechanical Problem	17	17
Failure to Cycle	17	17
Application Program Freezes or Fails to Launch	16	16
Device Markings/Labelling Problem	15	15
Obstruction of Flow	15	15
Data Problem	14	14
Pumping Problem	14	14
Noise, Audible	14	14

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	8882	8904
No Patient Involvement	790	790
Insufficient Information	163	165
No Information	38	38
No Consequences Or Impact To Patient	27	27
Unintended Extubation	15	15
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	9	9
Low Oxygen Saturation	6	6
Cardiac Arrest	5	5
Unspecified Tissue Injury	4	4
Laceration(s)	2	2
Respiratory Failure	2	2
Superficial (First Degree) Burn	1	1
Hypoventilation	1	1
Respiratory Arrest	1	1
Burn(s)	1	1
Foreign Body In Patient	1	1
Discomfort	1	1
Pain	1	1
Eye Injury	1	1
Anxiety	1	1
Cough	1	1
Hypoxia	1	1
Bacterial Infection	1	1
Respiratory Insufficiency	1	1
Bruise/Contusion	1	1
Lethargy	1	1