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
1. K203749 Ambu VivaSight 2 DLT, Ambu VivaSight 2 Adapter Cab ...
HYTEK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
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
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 Rupture	6	6
Material Puncture/Hole	6	6
Failure to Deflate	5	5
Unsealed Device Packaging	5	5
Material Split, Cut or Torn	5	5
Separation Failure	5	5
Obstruction of Flow	5	5
Incomplete or Missing Packaging	5	5
Defective Component	4	4
Contamination /Decontamination Problem	4	4
Unintended Deflation	4	4
Difficult to Insert	4	4
Device Damaged Prior to Use	3	3
Device Contaminated During Manufacture or Shipping	3	3
Material Integrity Problem	3	3
Detachment of Device or Device Component	3	3
Failure to Unfold or Unwrap	3	3
Material Too Soft/Flexible	3	3
Physical Resistance/Sticking	3	3
Deformation Due to Compressive Stress	2	2
No Flow	2	2
Packaging Problem	2	2
Shipping Damage or Problem	2	2
Incomplete or Inadequate Connection	2	2
Fluid/Blood Leak	2	2
Device Contamination with Chemical or Other Material	2	2
Positioning Failure	2	2
Complete Blockage	2	2
Blocked Connection	1	1
Defective Device	1	1
Connection Problem	1	1
Failure to Disconnect	1	1
Product Quality Problem	1	1
Device Markings/Labelling Problem	1	1
Decrease in Pressure	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
Ventilator Dependent	4	4
Decreased Respiratory Rate	4	4
No Information	4	4
Hemorrhage/Bleeding	3	3
Pain	3	3
No Known Impact Or Consequence To Patient	3	3
Pulmonary Embolism	2	2
Airway Obstruction	2	2
Exsanguination	2	2
Obstruction/Occlusion	2	2
Aspiration Pneumonitis	2	2
Unintended Extubation	2	2
Bradycardia	1	1
Death	1	1
Low Blood Pressure/ Hypotension	1	1
Hypoventilation	1	1
Laceration(s)	1	1
Sepsis	1	1
Septic Shock	1	1
Decreased Peak Expiratory Flow rate	1	1
Respiratory Failure	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