TPLC - Total Product Life Cycle

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Device	tube tracheostomy 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	1091	1091
Use of Device Problem	989	989
Inflation Problem	877	877
Leak/Splash	512	512
Defective Component	410	410
Material Split, Cut or Torn	376	376
Break	251	251
Connection Problem	221	221
Disconnection	163	163
Crack	142	142
Defective Device	125	125
Material Separation	118	118
Fluid/Blood Leak	116	116
Material Puncture/Hole	115	115
Appropriate Term/Code Not Available	101	101
Fracture	100	100
Insufficient Information	89	89
Detachment of Device or Device Component	88	88
Inadequacy of Device Shape and/or Size	80	80
Physical Resistance/Sticking	79	79
Human-Device Interface Problem	78	78
Material Discolored	71	71
Obstruction of Flow	66	66
Material Integrity Problem	59	59
Deflation Problem	59	59
Device Markings/Labelling Problem	54	54
Material Rupture	54	54
Material Fragmentation	50	50
Labelling, Instructions for Use or Training Problem	46	46
Mechanical Problem	45	45
Patient-Device Incompatibility	43	43
Patient Device Interaction Problem	43	43
Contamination	38	38
Component Missing	36	36
Material Deformation	32	32
Adverse Event Without Identified Device or Use Problem	30	30
Product Quality Problem	29	29
Unintended Deflation	28	28
Tear, Rip or Hole in Device Packaging	27	27
Difficult to Advance	27	27
Contamination /Decontamination Problem	26	26
Deformation Due to Compressive Stress	24	24
No Apparent Adverse Event	21	21
Difficult to Insert	21	21
Material Twisted/Bent	20	20
Separation Problem	20	20
Gel Leak	20	20
Difficult to Remove	19	19
Device-Device Incompatibility	18	18
Loose or Intermittent Connection	18	18

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2507	2507
Unintended Extubation	1272	1272
No Consequences Or Impact To Patient	815	815
Insufficient Information	694	694
Extubate	264	264
No Information	217	217
No Known Impact Or Consequence To Patient	207	207
Low Oxygen Saturation	166	166
No Patient Involvement	147	147
Hypoventilation	108	108
Decreased Respiratory Rate	78	78
Airway Obstruction	63	63
Dyspnea	56	56
Unspecified Tissue Injury	56	56
No Code Available	54	54
Respiratory Insufficiency	45	45
Hemorrhage/Bleeding	44	44
Respiratory Distress	39	39
Hypoxia	35	35
Discomfort	34	34
Death	31	31
Pain	29	29
Tachycardia	23	23
Skin Inflammation/ Irritation	23	23
Cardiac Arrest	18	18
Inflammation	17	17
Irritation	16	16
Aspiration/Inhalation	16	16
Distress	15	15
Respiratory Failure	15	15
Injury	14	14
Pneumonia	14	14
Unspecified Infection	14	14
Unspecified Respiratory Problem	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Pneumothorax	12	12
Foreign Body In Patient	11	11
Failure of Implant	9	9
Bradycardia	9	9
Pressure Sores	8	8
Respiratory Tract Infection	8	8
Dysphasia	8	8
Cough	7	7
Increased Respiratory Rate	7	7
Anxiety	7	7
Obstruction/Occlusion	7	7
Stenosis	7	7
Low Blood Pressure/ Hypotension	7	7
High Oxygen Saturation	7	7
Bacterial Infection	6	6