TPLC - Total Product Life Cycle

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Device	tube, tracheostomy (w/wo connector)
Regulation Description	Tracheostomy tube and tube cuff.
Product Code	BTO
Regulation Number	868.5800
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	400	402
Inflation Problem	188	192
Leak/Splash	177	178
Break	162	164
Detachment of Device or Device Component	121	123
Crack	104	105
Disconnection	97	99
Material Puncture/Hole	58	59
Material Split, Cut or Torn	57	57
Defective Component	55	55
Fluid/Blood Leak	52	52
Material Separation	52	52
Contamination /Decontamination Problem	45	45
Connection Problem	45	45
Component Missing	43	43
Unintended Deflation	43	43
Device Markings/Labelling Problem	37	37
Fracture	37	37
Deflation Problem	32	32
Separation Problem	29	30
Defective Device	28	30
Obstruction of Flow	22	23
Incomplete or Missing Packaging	22	22
Nonstandard Device	20	20
Material Deformation	20	20
Fitting Problem	19	19
Decrease in Pressure	19	19
Device Damaged Prior to Use	18	18
Material Rupture	17	17
Pressure Problem	17	17
Suction Problem	16	16
Mechanical Problem	16	17
Loose or Intermittent Connection	15	15
Tear, Rip or Hole in Device Packaging	13	13
Insufficient Information	13	13
Moisture or Humidity Problem	13	13
Inadequacy of Device Shape and/or Size	12	12
Device Dislodged or Dislocated	12	12
Use of Device Problem	12	12
Complete Blockage	11	11
Difficult to Insert	11	11
Patient Device Interaction Problem	11	12
Material Twisted/Bent	10	10
Gel Leak	10	10
Degraded	10	10
Physical Resistance/Sticking	8	8
Deformation Due to Compressive Stress	8	8
Misconnection	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Difficult to Remove	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1767	1782
Insufficient Information	229	230
Decreased Respiratory Rate	29	29
Low Oxygen Saturation	28	29
Airway Obstruction	14	16
Dyspnea	11	11
Unintended Extubation	9	9
Respiratory Insufficiency	9	9
Hypoxia	9	9
Hypoventilation	8	8
No Consequences Or Impact To Patient	8	8
Aspiration Pneumonitis	7	7
Aspiration/Inhalation	7	7
Cardiac Arrest	6	8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Hemorrhage/Bleeding	5	5
Bradycardia	5	5
Pneumonia	4	4
Fever	3	3
Device Embedded In Tissue or Plaque	2	2
Fistula	2	2
Ventilator Dependent	2	2
Swelling/ Edema	2	2
Pain	2	2
Respiratory Tract Infection	2	2
Chest Pain	2	2
Foreign Body In Patient	2	2
Blister	2	2
Failure of Implant	2	5
Brain Injury	2	2
Diminished Pulse Pressure	2	2
Skin Inflammation/ Irritation	2	2
No Information	2	2
Respiratory Arrest	2	2
Distress	1	1
Bruise/Contusion	1	1
Wound Dehiscence	1	1
Stacking Breaths	1	1
Apnea	1	1
Stomatitis	1	1
Respiratory Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Hypersensitivity/Allergic reaction	1	1
Pneumothorax	1	1
Decreased Sensitivity	1	1
Loss of consciousness	1	1
Sore Throat	1	1
Respiratory Distress Syndrome of Newborns	1	1
Bacterial Infection	1	1
Myocardial Hypertrophy	1	2