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	1310	1311
Use of Device Problem	1252	1253
Inflation Problem	821	821
Material Split, Cut or Torn	462	463
Defective Component	393	394
Break	245	247
Disconnection	228	228
Connection Problem	213	214
Leak/Splash	160	160
Material Separation	109	109
Appropriate Device Problem Term/Code Not Available	108	108
Crack	108	108
Defective Device	105	105
Fluid/Blood Leak	91	91
Insufficient Device Problem Information	85	85
Human-Device Interface Problem	81	81
Material Puncture/Hole	80	80
Fracture	78	78
Physical Resistance/Sticking	77	78
Obstruction of Flow	71	72
Detachment of Device or Device Component	56	56
Deflation Problem	53	53
Component Missing	47	47
Device Markings/Labelling Problem	47	47
Contamination	44	44
Patient-Device Incompatibility	41	42
Labelling, Instructions for Use or Training Problem	38	38
Patient Device Interaction Problem	36	36
Unintended Deflation	34	34
Difficult to Advance	33	33
Mechanical Problem	33	34
Material Discolored	31	31
Loss of or Failure to Bond	29	29
Inadequacy of Device Shape and/or Size	28	28
No Apparent Adverse Event	27	27
Material Deformation	27	27
Material Fragmentation	26	27
Product Quality Problem	26	26
Difficult to Insert	26	26
Material Integrity Problem	25	25
Device-Device Incompatibility	23	23
Deformation Due to Compressive Stress	21	21
Contamination /Decontamination Problem	21	21
Material Rupture	21	21
Adverse Event Without Identified Device or Use Problem	19	19
Fitting Problem	19	19
Failure to Deflate	19	19
Difficult to Remove	18	18
Gel Leak	18	18
Tear, Rip or Hole in Device Packaging	18	18

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	3648	3660
Unintended Extubation	1751	1755
Insufficient Information	807	814
Low Oxygen Saturation	156	156
Hypoventilation	112	112
Decreased Respiratory Rate	83	83
Dyspnea	63	63
Unspecified Tissue Injury	62	63
Hemorrhage/Blood Loss/Bleeding	60	60
Respiratory Insufficiency	59	59
Airway Obstruction	49	49
No Consequences Or Impact To Patient	46	46
Discomfort	40	40
Cardiac Arrest	25	26
Tachycardia	23	23
Skin Inflammation/ Irritation	23	23
Hypoxia	23	23
Pain	21	21
Aspiration/Inhalation	20	20
Respiratory Failure	15	15
Unspecified Respiratory Problem	14	14
Distress	14	14
Inflammation	14	14
Foreign Body In Patient	12	13
No Information	11	11
Cough	11	11
Unspecified Infection	11	12
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	11	11
Pneumonia	11	11
Upper Respiratory Tract Injury	10	10
Pressure Sore/Ulcer	10	10
No Patient Involvement	10	10
Bradycardia	9	9
Failure of Implant	9	9
Pneumothorax	8	8
High Oxygen Saturation	7	7
Bacterial Infection	7	7
Sore Throat	7	7
Respiratory Tract Infection	7	7
Obstruction/Occlusion	7	7
Increased Respiratory Rate	7	7
Hemoptysis	6	6
Device Embedded In Tissue or Plaque	6	6
Stenosis	6	6
Ventilator Dependent	6	7
Swelling/ Edema	5	5
Ulcer	5	5
Forced Expiratory Volume Decreased	5	5
Choking	5	5
Anxiety	5	5