TPLC - Total Product Life Cycle

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Device	tube tracheostomy and tube cuff
Product Code	JOH
Regulation Number	868.5800
Device Class	2

Premarket Reviews
Manufacturer	Decision
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
1. K193133 Blue Rhino G1-Multi Percutaneous Tracheostomy Intr ...
COVIDIEN
	SUBSTANTIALLY EQUIVALENT	2
SMITHS MEDICAL ASD, INC.
	SUBSTANTIALLY EQUIVALENT	1
TRACOE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	1167	1167
Use of Device Problem	1053	1053
Inflation Problem	897	897
Leak/Splash	513	513
Defective Component	414	414
Material Split, Cut or Torn	403	403
Break	259	259
Connection Problem	221	221
Disconnection	172	172
Crack	146	146
Defective Device	126	126
Material Separation	125	125
Fluid/Blood Leak	120	120
Material Puncture/Hole	116	116
Appropriate Term/Code Not Available	110	110
Fracture	103	103
Insufficient Information	92	92
Detachment of Device or Device Component	90	90
Physical Resistance/Sticking	84	84
Human-Device Interface Problem	81	81
Inadequacy of Device Shape and/or Size	80	80
Material Discolored	72	72
Obstruction of Flow	67	67
Material Integrity Problem	60	60
Deflation Problem	59	59
Material Rupture	56	56
Device Markings/Labelling Problem	54	54
Material Fragmentation	50	50
Labelling, Instructions for Use or Training Problem	46	46
Mechanical Problem	46	46
Patient Device Interaction Problem	43	43
Patient-Device Incompatibility	43	43
Contamination	39	39
Component Missing	36	36
Material Deformation	32	32
Adverse Event Without Identified Device or Use Problem	32	32
Product Quality Problem	29	29
Unintended Deflation	29	29
Tear, Rip or Hole in Device Packaging	27	27
Contamination /Decontamination Problem	27	27
Difficult to Advance	27	27
Deformation Due to Compressive Stress	24	24
Difficult to Insert	23	23
No Apparent Adverse Event	22	22
Separation Problem	21	21
Material Twisted/Bent	20	20
Gel Leak	20	20
Difficult to Remove	19	19
Fitting Problem	19	19
Device-Device Incompatibility	18	18

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2651	2651
Unintended Extubation	1364	1364
No Consequences Or Impact To Patient	815	815
Insufficient Information	721	721
Extubate	264	264
No Information	217	217
No Known Impact Or Consequence To Patient	207	207
Low Oxygen Saturation	178	178
No Patient Involvement	147	147
Hypoventilation	113	113
Decreased Respiratory Rate	82	82
Airway Obstruction	64	64
Dyspnea	59	59
Unspecified Tissue Injury	57	57
No Code Available	54	54
Hemorrhage/Bleeding	51	51
Respiratory Insufficiency	47	47
Respiratory Distress	39	39
Discomfort	38	38
Hypoxia	36	36
Death	31	31
Pain	30	30
Tachycardia	26	26
Skin Inflammation/ Irritation	24	24
Inflammation	21	21
Cardiac Arrest	19	19
Irritation	16	16
Aspiration/Inhalation	16	16
Distress	15	15
Respiratory Failure	15	15
Injury	14	14
Pneumonia	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Unspecified Infection	14	14
Unspecified Respiratory Problem	13	13
Pneumothorax	12	12
Foreign Body In Patient	11	11
Bradycardia	10	10
Failure of Implant	9	9
Pressure Sores	8	8
Cough	8	8
Respiratory Tract Infection	8	8
Dysphasia	8	8
Increased Respiratory Rate	7	7
Anxiety	7	7
Obstruction/Occlusion	7	7
Stenosis	7	7
Low Blood Pressure/ Hypotension	7	7
High Oxygen Saturation	7	7
Bacterial Infection	6	6