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	3
INVENTEUR, LLC
	SUBSTANTIALLY EQUIVALENT	1
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
1. K172365 Panoramic Oxygen Mask (POM)
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	3379	3379
Communication or Transmission Problem	2684	2684
Crack	2370	2370
Corroded	1002	1002
Appropriate Term/Code Not Available	944	944
Failure to Calibrate	918	918
Incorrect, Inadequate or Imprecise Result or Readings	737	737
Device Alarm System	637	637
Computer Software Problem	564	564
Contamination	528	528
Failure of Device to Self-Test	485	485
No Device Output	472	472
Loose or Intermittent Connection	419	419
No Apparent Adverse Event	416	416
Calibration Problem	389	389
Circuit Failure	301	301
Insufficient Information	295	295
Output Problem	221	221
Device Sensing Problem	184	184
Physical Resistance/Sticking	125	125
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	59	59
Incorrect Measurement	58	58
Misassembled	50	50
Low Readings	46	46
High Readings	40	40
Failure to Power Up	39	39
Peeled/Delaminated	38	38
Pumping Stopped	37	37
Missing Information	37	37
Degraded	28	28
Application Program Problem	28	28
Naturally Worn	28	28
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
Unexpected Shutdown	13	13
Device Displays Incorrect Message	13	13
Noise, Audible	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	6873	6873
No Patient Involvement	3000	3000
No Known Impact Or Consequence To Patient	146	146
No Consequences Or Impact To Patient	143	143
Insufficient Information	127	127
No Information	88	88
Unintended Extubation	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	8	8
Low Oxygen Saturation	5	5
Cardiac Arrest	4	4
Unspecified Tissue Injury	4	4
Foreign Body In Patient	3	3
Hypoxia	3	3
Death	2	2
Respiratory Distress	2	2
Pain	2	2
Cyanosis	1	1
Patient Problem/Medical Problem	1	1
Superficial (First Degree) Burn	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
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
Bruise/Contusion	1	1