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
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
Material Deformation	11	11
Crack	11	11
Component Missing	10	10
Structural Problem	10	10
Fracture	10	10
Material Separation	8	8
Material Twisted/Bent	8	8
Use of Device Problem	7	7
Material Too Soft/Flexible	7	7
Infusion or Flow Problem	7	7
Material Puncture/Hole	6	6
Material Split, Cut or Torn	6	6
Mechanical Problem	6	6
Unsealed Device Packaging	5	5
Failure to Deflate	5	5
Fluid/Blood Leak	5	5
Separation Failure	5	5
Obstruction of Flow	5	5
Incomplete or Missing Packaging	5	5
Difficult to Insert	4	4
Unintended Deflation	4	4
Defective Component	4	4
Device Contaminated During Manufacture or Shipping	3	3
Material Integrity Problem	3	4
Detachment of Device or Device Component	3	3
Contamination /Decontamination Problem	3	3
Device Damaged Prior to Use	3	3
Physical Resistance/Sticking	3	3
Product Quality Problem	3	3
Failure to Unfold or Unwrap	3	3
Device Contamination with Chemical or Other Material	2	2
Device Markings/Labelling Problem	2	2
Packaging Problem	2	2
Deformation Due to Compressive Stress	2	2
Device Damaged Prior to Receipt by User	2	2
Incomplete or Inadequate Connection	2	2
Positioning Failure	2	2
Complete Blockage	2	2
Material Too Rigid or Stiff	1	1
Decrease in Pressure	1	1
Delivered as Unsterile Product	1	1
Inadequacy of Device Shape and/or Size	1	1
Blocked Connection	1	1
Misconnection	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