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	1288	1297
Use of Device Problem	1219	1222
Inflation Problem	901	905
Material Split, Cut or Torn	477	477
Defective Component	424	424
Leak/Splash	295	296
Break	256	256
Disconnection	233	233
Connection Problem	215	215
Material Separation	126	126
Fluid/Blood Leak	119	119
Crack	115	115
Appropriate Term/Code Not Available	114	114
Defective Device	114	114
Material Puncture/Hole	93	93
Insufficient Information	90	90
Fracture	86	86
Physical Resistance/Sticking	79	79
Human-Device Interface Problem	75	75
Obstruction of Flow	63	65
Deflation Problem	59	61
Device Markings/Labelling Problem	54	54
Detachment of Device or Device Component	50	50
Inadequacy of Device Shape and/or Size	49	49
Material Fragmentation	45	45
Labelling, Instructions for Use or Training Problem	44	44
Material Rupture	43	43
Contamination	43	43
Patient Device Interaction Problem	42	42
Patient-Device Incompatibility	41	41
Mechanical Problem	40	40
Material Discolored	40	40
Material Integrity Problem	39	39
Component Missing	36	36
Unintended Deflation	34	34
Difficult to Advance	33	33
Material Deformation	32	32
No Apparent Adverse Event	30	30
Product Quality Problem	28	30
Tear, Rip or Hole in Device Packaging	28	28
Difficult to Insert	24	24
Adverse Event Without Identified Device or Use Problem	23	23
Contamination /Decontamination Problem	23	23
Device-Device Incompatibility	23	23
Deformation Due to Compressive Stress	22	22
Fitting Problem	21	21
Material Twisted/Bent	20	20
Loose or Intermittent Connection	18	18
Gel Leak	18	18
Failure to Deflate	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3333	3343
Unintended Extubation	1607	1607
Insufficient Information	770	776
No Consequences Or Impact To Patient	450	450
Low Oxygen Saturation	167	167
Extubate	123	123
Hypoventilation	122	122
Decreased Respiratory Rate	82	82
No Patient Involvement	76	76
No Information	68	68
Unspecified Tissue Injury	61	61
Airway Obstruction	58	58
Hemorrhage/Bleeding	58	58
Dyspnea	56	56
Respiratory Insufficiency	55	55
Discomfort	38	38
Hypoxia	28	28
Tachycardia	25	25
Pain	24	24
Skin Inflammation/ Irritation	24	24
Cardiac Arrest	22	22
Distress	20	20
Death	18	18
Aspiration/Inhalation	18	18
No Code Available	17	17
Respiratory Failure	16	16
Foreign Body In Patient	15	15
Respiratory Distress	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	14	14
Unspecified Infection	14	15
Unspecified Respiratory Problem	13	13
Inflammation	13	13
Pneumonia	13	13
Pressure Sores	11	11
Cough	11	11
Pneumothorax	11	11
Injury	11	11
Bradycardia	10	10
No Known Impact Or Consequence To Patient	10	10
Failure of Implant	9	9
Respiratory Tract Infection	8	8
Dysphasia	8	8
Bacterial Infection	7	7
Sore Throat	7	7
High Oxygen Saturation	7	7
Anxiety	7	7
Stenosis	7	7
Obstruction/Occlusion	7	7
Increased Respiratory Rate	6	6
Low Blood Pressure/ Hypotension	6	6