TPLC - Total Product Life Cycle

show TPLC since

Device	tube, bronchial (w/wo connector)
Regulation Description	Bronchial tube.
Product Code	BTS
Regulation Number	868.5720
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	368	368
Gas/Air Leak	248	248
Leak/Splash	90	91
Material Split, Cut or Torn	65	65
Defective Component	26	26
Break	23	23
Inflation Problem	15	15
Fluid/Blood Leak	13	13
Insufficient Device Problem Information	11	11
Material Separation	10	10
Appropriate Device Problem Term/Code Not Available	9	9
Crack	8	8
Material Integrity Problem	8	8
Obstruction of Flow	6	6
Nonstandard Device	6	6
Detachment of Device or Device Component	5	5
Installation-Related Problem	5	5
Contamination /Decontamination Problem	5	5
Material Rupture	4	4
Sharp Edges	4	4
Material Puncture/Hole	4	4
Material Fragmentation	4	4
Connection Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Human-Device Interface Problem	3	3
Mechanical Problem	3	3
Fitting Problem	3	3
Disconnection	3	3
Positioning Failure	2	2
Material Discolored	2	2
Unintended Movement	2	2
Complete Blockage	2	2
Device Markings/Labelling Problem	2	2
Material Deformation	2	2
Tear, Rip or Hole in Device Packaging	2	2
Missing Information	1	1
No Apparent Adverse Event	1	1
Fracture	1	1
Ambient Noise Problem	1	1
Product Quality Problem	1	1
Partial Blockage	1	1
Failure to Deflate	1	1
Difficult to Open or Close	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Insufficient Flow or Under Infusion	1	1
Material Twisted/Bent	1	1
Component Missing	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Patient Device Interaction Problem	1	1
Scratched Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	752	753
Unintended Extubation	102	102
Insufficient Information	48	48
Low Oxygen Saturation	17	17
Unspecified Tissue Injury	12	12
Hemorrhage/Blood Loss/Bleeding	4	4
Tissue Breakdown	4	4
Adult Respiratory Distress Syndrome	3	3
Foreign Body In Patient	3	3
Laceration(s)	3	3
Pain	3	3
Hypoventilation	2	2
Arrhythmia	1	1
Pneumothorax	1	1
Perforation of Esophagus	1	1
Dyspnea	1	1
Dysphagia/ Odynophagia	1	1
Sore Throat	1	1
Low Blood Pressure/ Hypotension	1	1
Ventilator Dependent	1	1
Decreased Respiratory Rate	1	1
Fistula	1	1
Device Embedded In Tissue or Plaque	1	1
Unintended Radiation Exposure	1	1