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
AMBUA/S
	SUBSTANTIALLY EQUIVALENT	1
HYTEK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSUNG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PULMONX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
1. K222340 Chartis Precision Catheter
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	86	86
Leak/Splash	80	80
Inflation Problem	72	72
Deflation Problem	28	28
Material Rupture	12	12
Crack	11	11
Fracture	10	10
Material Deformation	10	10
Component Missing	10	10
Material Separation	8	8
Structural Problem	8	8
Material Twisted/Bent	8	8
Infusion or Flow Problem	7	7
Use of Device Problem	7	7
Mechanical Problem	6	6
Material Puncture/Hole	6	6
Fluid/Blood Leak	5	5
Failure to Deflate	5	5
Obstruction of Flow	5	5
Unsealed Device Packaging	5	5
Material Split, Cut or Torn	5	5
Separation Failure	5	5
Incomplete or Missing Packaging	5	5
Defective Component	4	4
Material Too Soft/Flexible	4	4
Unintended Deflation	4	4
Contamination /Decontamination Problem	4	4
Difficult to Insert	4	4
Material Integrity Problem	3	4
Device Contaminated During Manufacture or Shipping	3	3
Detachment of Device or Device Component	3	3
Failure to Unfold or Unwrap	3	3
Physical Resistance/Sticking	3	3
Device Damaged Prior to Use	3	3
No Flow	2	2
Deformation Due to Compressive Stress	2	2
Device Contamination with Chemical or Other Material	2	2
Packaging Problem	2	2
Incomplete or Inadequate Connection	2	2
Device Markings/Labelling Problem	2	2
Complete Blockage	2	2
Positioning Failure	2	2
Shipping Damage or Problem	2	2
Material Perforation	1	1
Activation Problem	1	1
Blocked Connection	1	1
Decrease in Pressure	1	1
Sharp Edges	1	1
Misconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	461	461
Insufficient Information	53	53
No Consequences Or Impact To Patient	42	42
No Patient Involvement	25	25
Low Oxygen Saturation	15	15
No Information	4	4
Pain	4	4
Ventilator Dependent	4	4
Decreased Respiratory Rate	4	4
No Known Impact Or Consequence To Patient	3	3
Hemorrhage/Bleeding	3	3
Exsanguination	2	2
Obstruction/Occlusion	2	2
Airway Obstruction	2	2
Unintended Extubation	2	2
Pulmonary Embolism	2	2
Aspiration Pneumonitis	2	2
Patient Problem/Medical Problem	1	1
Death	1	1
Hypoventilation	1	1
Sepsis	1	1
Decreased Peak Expiratory Flow rate	1	1
Foreign Body In Patient	1	1
Septic Shock	1	1
Laceration(s)	1	1
Unspecified Kidney or Urinary Problem	1	1
Bradycardia	1	1
Unspecified Respiratory Problem	1	2
Respiratory Insufficiency	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Failure	1	1