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
INSUNG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
1. K200968 ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, AB ...
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 Puncture/Hole	6	6
Material Rupture	6	6
Material Split, Cut or Torn	5	5
Incomplete or Missing Packaging	5	5
Failure to Deflate	5	5
Separation Failure	5	5
Unsealed Device Packaging	5	5
Obstruction of Flow	5	5
Unintended Deflation	4	4
Defective Component	4	4
Contamination /Decontamination Problem	4	4
Difficult to Insert	4	4
Device Contaminated During Manufacture or Shipping	3	3
Physical Resistance/Sticking	3	3
Material Too Soft/Flexible	3	3
Device Damaged Prior to Use	3	3
Detachment of Device or Device Component	3	3
Failure to Unfold or Unwrap	3	3
Material Integrity Problem	3	3
Fluid/Blood Leak	2	2
No Flow	2	2
Deformation Due to Compressive Stress	2	2
Device Contamination with Chemical or Other Material	2	2
Packaging Problem	2	2
Positioning Failure	2	2
Shipping Damage or Problem	2	2
Complete Blockage	2	2
Incomplete or Inadequate Connection	2	2
Decrease in Pressure	1	1
Material Perforation	1	1
Material Too Rigid or Stiff	1	1
Blocked Connection	1	1
Sharp Edges	1	1
Device Misassembled During Manufacturing /Shipping	1	1
Misconnection	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
No Known Impact Or Consequence To Patient	3	3
Pain	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	1
Respiratory Insufficiency	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Failure	1	1