TPLC - Total Product Life Cycle

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Device	tube, tracheal/bronchial, differential ventilation (w/wo connector)
Regulation Description	Tracheal/bronchial differential ventilation tube.
Product Code	CBI
Regulation Number	868.5740
Device Class	2

Premarket Reviews
Manufacturer	Decision
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	1
HANGZHOU TAPPA MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
HYTEK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSUNG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PULMONX CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
1. K222340 Chartis Precision Catheter
2. K253096 Chartis Precision Catheter
SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	180	180
Gas/Air Leak	101	101
Leak/Splash	85	85
Inflation Problem	81	81
Deflation Problem	30	30
Material Rupture	14	14
Crack	11	11
Material Deformation	11	11
Fracture	10	10
Structural Problem	10	10
Component Missing	10	10
Material Twisted/Bent	8	8
Material Separation	8	8
Material Too Soft/Flexible	7	7
Infusion or Flow Problem	7	7
Use of Device Problem	7	7
Material Split, Cut or Torn	6	6
Mechanical Problem	6	6
Material Puncture/Hole	6	6
Failure to Deflate	5	5
Fluid/Blood Leak	5	5
Separation Failure	5	5
Unsealed Device Packaging	5	5
Obstruction of Flow	5	5
Incomplete or Missing Packaging	5	5
Unintended Deflation	4	4
Defective Component	4	4
Difficult to Insert	4	4
Failure to Unfold or Unwrap	3	3
Device Damaged Prior to Use	3	3
Product Quality Problem	3	3
Physical Resistance/Sticking	3	3
Contamination /Decontamination Problem	3	3
Detachment of Device or Device Component	3	3
Device Contaminated During Manufacture or Shipping	3	3
Material Integrity Problem	3	4
Complete Blockage	2	2
Incomplete or Inadequate Connection	2	2
Device Damaged Prior to Receipt by User	2	2
Positioning Failure	2	2
Deformation Due to Compressive Stress	2	2
Device Markings/Labelling Problem	2	2
Packaging Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Burst Container or Vessel	1	1
Activation Problem	1	1
Device Fell	1	1
Sharp Edges	1	1
Contamination	1	1
Device Handling Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	492	492
Insufficient Information	60	60
No Consequences Or Impact To Patient	42	42
No Patient Involvement	25	25
Low Oxygen Saturation	15	15
Upper Respiratory Tract Injury	5	5
Pain	4	4
Decreased Respiratory Rate	4	4
No Information	4	4
Ventilator Dependent	4	4
Hemorrhage/Blood Loss/Bleeding	3	3
No Known Impact Or Consequence To Patient	3	3
Aspiration Pneumonitis	2	2
Pulmonary Embolism	2	2
Exsanguination	2	2
Unintended Extubation	2	2
Hypoxia	2	2
Airway Obstruction	2	2
Obstruction/Occlusion	2	2
Bradycardia	1	1
Low Blood Pressure/ Hypotension	1	1
Laceration(s)	1	1
Patient Problem/Medical Problem	1	1
Septic Shock	1	1
Hypoventilation	1	1
Sepsis	1	1
Respiratory Insufficiency	1	1
Death	1	1
Respiratory Failure	1	1
Unspecified Kidney or Urinary Problem	1	1
Foreign Body In Patient	1	1
Decreased Peak Expiratory Flow rate	1	1
Unspecified Respiratory Problem	1	2