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
HYTEK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K201026 sOLVe Tube
INSUNG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PULMONX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	182	182
Gas/Air Leak	83	83
Inflation Problem	65	65
Leak/Splash	59	59
Deflation Problem	24	24
Crack	10	10
Material Deformation	10	10
Fracture	10	10
Component Missing	10	10
Material Twisted/Bent	8	8
Structural Problem	8	8
Material Separation	8	8
Infusion or Flow Problem	7	7
Use of Device Problem	7	7
Mechanical Problem	6	6
Material Puncture/Hole	6	6
Material Rupture	6	6
Failure to Deflate	5	5
Material Split, Cut or Torn	5	5
Separation Failure	5	5
Obstruction of Flow	5	5
Incomplete or Missing Packaging	5	5
Unsealed Device Packaging	5	5
Unintended Deflation	4	4
Defective Component	4	4
Difficult to Insert	4	4
Contamination /Decontamination Problem	4	4
Failure to Unfold or Unwrap	3	3
Physical Resistance/Sticking	3	3
Device Damaged Prior to Use	3	3
Material Too Soft/Flexible	3	3
Detachment of Device or Device Component	3	3
Material Integrity Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Shipping Damage or Problem	2	2
Incomplete or Inadequate Connection	2	2
Complete Blockage	2	2
Packaging Problem	2	2
Deformation Due to Compressive Stress	2	2
No Flow	2	2
Device Contamination with Chemical or Other Material	2	2
Fluid/Blood Leak	2	2
Positioning Failure	2	2
Burst Container or Vessel	1	1
Activation Problem	1	1
Device Fell	1	1
Sharp Edges	1	1
Device Handling Problem	1	1
Appropriate Term/Code Not Available	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	423	423
Insufficient Information	51	51
No Consequences Or Impact To Patient	42	42
No Patient Involvement	25	25
Low Oxygen Saturation	14	14
No Information	4	4
Ventilator Dependent	4	4
Decreased Respiratory Rate	4	4
Pain	3	3
No Known Impact Or Consequence To Patient	3	3
Hemorrhage/Bleeding	3	3
Aspiration Pneumonitis	2	2
Pulmonary Embolism	2	2
Airway Obstruction	2	2
Exsanguination	2	2
Obstruction/Occlusion	2	2
Unintended Extubation	2	2
Laceration(s)	1	1
Sepsis	1	1
Septic Shock	1	1
Foreign Body In Patient	1	1
Patient Problem/Medical Problem	1	1
Respiratory Insufficiency	1	1
Unspecified Respiratory Problem	1	1
Unspecified Kidney or Urinary Problem	1	1
Bradycardia	1	1
Death	1	1
Low Blood Pressure/ Hypotension	1	1
Hypoventilation	1	1
Decreased Peak Expiratory Flow rate	1	1
Respiratory Failure	1	1