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
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
1. K192563 Altera gas Sampling Lines
ORANTECH INC.
	SUBSTANTIALLY EQUIVALENT	1
ORIDION MEDICAL 1987 LTD.
	SUBSTANTIALLY EQUIVALENT	3
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
VYAIRE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	3344	3344
Communication or Transmission Problem	2591	2591
Crack	2335	2335
Corroded	978	978
Appropriate Term/Code Not Available	944	944
Failure to Calibrate	897	897
Incorrect, Inadequate or Imprecise Result or Readings	733	733
Device Alarm System	629	629
Computer Software Problem	564	564
Contamination	527	527
Failure of Device to Self-Test	478	478
No Device Output	467	467
Loose or Intermittent Connection	417	417
No Apparent Adverse Event	413	413
Calibration Problem	379	379
Circuit Failure	300	300
Insufficient Information	295	295
Output Problem	218	218
Device Sensing Problem	180	180
Physical Resistance/Sticking	119	119
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	57	57
Incorrect Measurement	55	55
Misassembled	49	49
Low Readings	45	45
High Readings	40	40
Failure to Power Up	39	39
Peeled/Delaminated	38	38
Pumping Stopped	37	37
Missing Information	31	31
Naturally Worn	28	28
Degraded	28	28
Application Program Problem	27	27
Failure to Cycle	25	25
Electrical /Electronic Property Problem	24	24
Power Problem	22	22
Gas Output Problem	20	20
Temperature Problem	20	20
Image Display Error/Artifact	19	19
Mechanical Problem	18	18
No Display/Image	17	17
Device Markings/Labelling Problem	15	15
Erratic or Intermittent Display	14	14
Noise, Audible	13	13
Unexpected Shutdown	13	13
False Alarm	12	12
Use of Device Problem	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6751	6751
No Patient Involvement	2990	2990
No Consequences Or Impact To Patient	132	132
Insufficient Information	122	122
No Known Impact Or Consequence To Patient	114	114
No Information	81	81
Unintended Extubation	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Cardiac Arrest	4	4
Unspecified Tissue Injury	4	4
Foreign Body In Patient	3	3
Low Oxygen Saturation	3	3
Death	2	2
Respiratory Distress	2	2
Pain	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
Hypoventilation	1	1
Respiratory Arrest	1	1
Perforation	1	1
Injury	1	1
Chest Pain	1	1
Discomfort	1	1
Cardiopulmonary Arrest	1	1
Laceration(s)	1	1
Anxiety	1	1
Cough	1	1
Pressure Sores	1	1
Inadequate Pain Relief	1	1
Extubate	1	1
Respiratory Insufficiency	1	1
Bruise/Contusion	1	1
Lethargy	1	1