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	1283	1292
Use of Device Problem	1188	1192
Inflation Problem	839	843
Material Split, Cut or Torn	450	451
Defective Component	392	393
Break	232	234
Disconnection	225	225
Connection Problem	201	202
Leak/Splash	183	184
Defective Device	113	113
Material Separation	113	113
Crack	106	106
Appropriate Term/Code Not Available	104	104
Fluid/Blood Leak	89	89
Insufficient Information	85	85
Material Puncture/Hole	84	84
Fracture	79	79
Physical Resistance/Sticking	78	79
Human-Device Interface Problem	75	75
Obstruction of Flow	69	71
Deflation Problem	56	58
Detachment of Device or Device Component	54	54
Device Markings/Labelling Problem	50	50
Contamination	44	44
Patient-Device Incompatibility	41	42
Labelling, Instructions for Use or Training Problem	37	37
Patient Device Interaction Problem	36	36
Component Missing	36	36
Unintended Deflation	34	34
Difficult to Advance	33	33
Material Discolored	32	32
Inadequacy of Device Shape and/or Size	32	32
Mechanical Problem	32	33
No Apparent Adverse Event	27	27
Product Quality Problem	27	29
Material Rupture	27	27
Material Integrity Problem	27	27
Material Deformation	26	26
Difficult to Insert	26	26
Material Fragmentation	26	27
Device-Device Incompatibility	23	23
Deformation Due to Compressive Stress	21	21
Loss of or Failure to Bond	21	21
Contamination /Decontamination Problem	21	21
Adverse Event Without Identified Device or Use Problem	20	20
Material Twisted/Bent	19	19
Gel Leak	18	18
Fitting Problem	18	18
Failure to Deflate	17	17
Microbial Contamination of Device	17	17

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3494	3506
Unintended Extubation	1673	1676
Insufficient Information	780	787
Low Oxygen Saturation	153	153
Hypoventilation	107	107
Decreased Respiratory Rate	83	83
Unspecified Tissue Injury	62	63
Hemorrhage/Bleeding	58	58
Dyspnea	56	56
Respiratory Insufficiency	56	56
Airway Obstruction	47	47
No Consequences Or Impact To Patient	46	46
Discomfort	39	39
Cardiac Arrest	24	25
Tachycardia	22	22
Hypoxia	22	22
Skin Inflammation/ Irritation	22	22
Pain	21	21
Aspiration/Inhalation	20	20
Distress	14	14
Respiratory Failure	14	14
Unspecified Respiratory Problem	14	14
Inflammation	14	14
Foreign Body In Patient	12	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Unspecified Infection	11	12
Pneumonia	11	11
Cough	11	11
No Information	11	11
No Patient Involvement	10	10
Pressure Sores	10	10
Bradycardia	9	9
Failure of Implant	9	9
Pneumothorax	8	8
Bacterial Infection	7	7
Obstruction/Occlusion	7	7
Sore Throat	7	7
High Oxygen Saturation	7	7
Respiratory Tract Infection	7	7
Hemoptysis	6	6
Stenosis	6	6
Increased Respiratory Rate	6	6
Ventilator Dependent	6	7
Device Embedded In Tissue or Plaque	6	6
Ulcer	5	5
Forced Expiratory Volume Decreased	5	5
Anxiety	5	5
Swelling/ Edema	5	5
Choking	5	5
Irritability	4	4