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	374	376
Inflation Problem	185	189
Leak/Splash	176	177
Break	150	152
Detachment of Device or Device Component	118	120
Crack	95	96
Disconnection	94	96
Material Split, Cut or Torn	55	55
Material Puncture/Hole	55	56
Defective Component	54	54
Material Separation	52	52
Fluid/Blood Leak	48	48
Contamination /Decontamination Problem	45	45
Connection Problem	45	45
Unintended Deflation	43	43
Component Missing	43	43
Device Markings/Labelling Problem	37	37
Fracture	37	37
Deflation Problem	32	32
Separation Problem	29	30
Defective Device	28	30
Incomplete or Missing Packaging	22	22
Obstruction of Flow	22	23
Nonstandard Device	20	20
Material Deformation	20	20
Decrease in Pressure	19	19
Device Damaged Prior to Use	18	18
Fitting Problem	18	18
Suction Problem	16	16
Mechanical Problem	15	16
Material Rupture	15	15
Loose or Intermittent Connection	15	15
Pressure Problem	14	14
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
Use of Device Problem	12	12
Device Dislodged or Dislocated	11	11
Difficult to Insert	11	11
Patient Device Interaction Problem	11	12
Gel Leak	10	10
Material Twisted/Bent	10	10
Degraded	10	10
Physical Resistance/Sticking	8	8
Complete Blockage	8	8
Deformation Due to Compressive Stress	8	8
Misconnection	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Material Integrity Problem	7	7

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1698	1713
Insufficient Information	227	228
Decreased Respiratory Rate	29	29
Low Oxygen Saturation	27	28
Airway Obstruction	14	16
Unintended Extubation	9	9
Respiratory Insufficiency	8	8
No Consequences Or Impact To Patient	8	8
Dyspnea	8	8
Aspiration Pneumonitis	7	7
Hypoventilation	7	7
Aspiration/Inhalation	7	7
Hypoxia	6	6
Cardiac Arrest	6	8
Hemorrhage/Bleeding	5	5
Bradycardia	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Pneumonia	4	4
Fever	3	3
Skin Inflammation/ Irritation	2	2
Diminished Pulse Pressure	2	2
No Information	2	2
Fistula	2	2
Device Embedded In Tissue or Plaque	2	2
Blister	2	2
Ventilator Dependent	2	2
Foreign Body In Patient	2	2
Chest Pain	2	2
Failure of Implant	2	5
Brain Injury	2	2
Swelling/ Edema	2	2
Bruise/Contusion	1	1
Stomatitis	1	1
Respiratory Failure	1	1
Hypersensitivity/Allergic reaction	1	1
Low Blood Pressure/ Hypotension	1	1
Apnea	1	1
Pneumothorax	1	1
Wound Dehiscence	1	1
Loss of consciousness	1	1
Bacterial Infection	1	1
Sore Throat	1	1
Stacking Breaths	1	1
Decreased Sensitivity	1	1
Unspecified Respiratory Problem	1	1
Myocardial Hypertrophy	1	2
Tachycardia	1	1
Bronchospasm	1	1
Forced Expiratory Volume Decreased	1	1
Salivary Hypersecretion	1	1