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
1. K201026 sOLVe Tube
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
Fracture	10	10
Structural Problem	10	10
Component Missing	10	10
Material Separation	8	8
Material Twisted/Bent	8	8
Material Too Soft/Flexible	7	7
Use of Device Problem	7	7
Infusion or Flow Problem	7	7
Mechanical Problem	6	6
Material Split, Cut or Torn	6	6
Material Puncture/Hole	6	6
Incomplete or Missing Packaging	5	5
Obstruction of Flow	5	5
Failure to Deflate	5	5
Unsealed Device Packaging	5	5
Fluid/Blood Leak	5	5
Separation Failure	5	5
Defective Component	4	4
Difficult to Insert	4	4
Unintended Deflation	4	4
Physical Resistance/Sticking	3	3
Product Quality Problem	3	3
Detachment of Device or Device Component	3	3
Contamination /Decontamination Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Material Integrity Problem	3	4
Device Damaged Prior to Use	3	3
Failure to Unfold or Unwrap	3	3
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
Device Contamination with Chemical or Other Material	2	2
Packaging Problem	2	2
Complete Blockage	2	2
Incomplete or Inadequate Connection	2	2
Burst Container or Vessel	1	1
Disconnection	1	1
Delivered as Unsterile Product	1	1
Material Too Rigid or Stiff	1	1
Contamination	1	1
Defective Device	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
Obstruction/Occlusion	2	2
Airway Obstruction	2	2
Hypoxia	2	2
Death	1	1
Hypoventilation	1	1
Laceration(s)	1	1
Patient Problem/Medical Problem	1	1
Septic Shock	1	1
Low Blood Pressure/ Hypotension	1	1
Sepsis	1	1
Respiratory Insufficiency	1	1
Foreign Body In Patient	1	1
Respiratory Failure	1	1
Unspecified Kidney or Urinary Problem	1	1
Bradycardia	1	1
Unspecified Respiratory Problem	1	2
Decreased Peak Expiratory Flow rate	1	1