TPLC - Total Product Life Cycle

show TPLC since

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
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	91	91
Leak/Splash	83	83
Inflation Problem	74	74
Deflation Problem	29	29
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
Material Too Soft/Flexible	7	7
Infusion or Flow Problem	7	7
Use of Device Problem	7	7
Material Split, Cut or Torn	6	6
Mechanical Problem	6	6
Material Puncture/Hole	6	6
Fluid/Blood Leak	5	5
Failure to Deflate	5	5
Obstruction of Flow	5	5
Incomplete or Missing Packaging	5	5
Unsealed Device Packaging	5	5
Separation Failure	5	5
Defective Component	4	4
Contamination /Decontamination Problem	4	4
Difficult to Insert	4	4
Unintended Deflation	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
Blocked Connection	1	1
Decrease in Pressure	1	1
Sharp Edges	1	1
Activation Problem	1	1
Misconnection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	473	473
Insufficient Information	54	54
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