TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	1223	1223
Use of Device Problem	1119	1119
Inflation Problem	876	876
Material Split, Cut or Torn	433	433
Defective Component	415	415
Leak/Splash	286	286
Break	249	249
Disconnection	229	229
Connection Problem	212	212
Material Separation	117	117
Defective Device	112	112
Appropriate Term/Code Not Available	110	110
Fluid/Blood Leak	109	109
Crack	106	106
Insufficient Information	90	90
Material Puncture/Hole	88	88
Fracture	85	85
Physical Resistance/Sticking	78	78
Human-Device Interface Problem	72	72
Obstruction of Flow	60	60
Deflation Problem	58	58
Device Markings/Labelling Problem	54	54
Inadequacy of Device Shape and/or Size	48	48
Material Fragmentation	45	45
Labelling, Instructions for Use or Training Problem	44	44
Material Rupture	43	43
Patient Device Interaction Problem	42	42
Contamination	41	41
Patient-Device Incompatibility	41	41
Material Discolored	40	40
Mechanical Problem	38	38
Material Integrity Problem	38	38
Detachment of Device or Device Component	35	35
Component Missing	35	35
Unintended Deflation	32	32
Material Deformation	31	31
No Apparent Adverse Event	30	30
Difficult to Advance	30	30
Tear, Rip or Hole in Device Packaging	28	28
Product Quality Problem	27	27
Adverse Event Without Identified Device or Use Problem	23	23
Difficult to Insert	23	23
Contamination /Decontamination Problem	22	22
Deformation Due to Compressive Stress	22	22
Material Twisted/Bent	20	20
Device-Device Incompatibility	20	20
Fitting Problem	19	19
Gel Leak	18	18
Loose or Intermittent Connection	18	18
Microbial Contamination of Device	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3127	3127
Unintended Extubation	1525	1525
Insufficient Information	752	752
No Consequences Or Impact To Patient	450	450
Low Oxygen Saturation	160	160
Extubate	123	123
Hypoventilation	113	113
Decreased Respiratory Rate	82	82
No Patient Involvement	76	76
No Information	68	68
Airway Obstruction	59	59
Unspecified Tissue Injury	58	58
Hemorrhage/Bleeding	57	57
Dyspnea	54	54
Respiratory Insufficiency	50	50
Discomfort	35	35
Tachycardia	25	25
Hypoxia	25	25
Pain	24	24
Skin Inflammation/ Irritation	24	24
Cardiac Arrest	20	20
Distress	19	19
Death	18	18
No Code Available	17	17
Aspiration/Inhalation	17	17
Foreign Body In Patient	15	15
Respiratory Distress	14	14
Respiratory Failure	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Unspecified Respiratory Problem	13	13
Inflammation	13	13
Pneumonia	12	12
Cough	11	11
Injury	11	11
Unspecified Infection	11	11
Pneumothorax	11	11
No Known Impact Or Consequence To Patient	10	10
Bradycardia	10	10
Failure of Implant	9	9
Dysphasia	8	8
Respiratory Tract Infection	8	8
Pressure Sores	7	7
Sore Throat	7	7
Obstruction/Occlusion	7	7
High Oxygen Saturation	7	7
Stenosis	6	6
Anxiety	6	6
Ventilator Dependent	6	6
Irritation	6	6
Increased Respiratory Rate	6	6