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
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	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
Material Twisted/Bent	8	8
Structural Problem	8	8
Infusion or Flow Problem	7	7
Use of Device Problem	7	7
Mechanical Problem	6	6
Material Puncture/Hole	6	6
Incomplete or Missing Packaging	5	5
Obstruction of Flow	5	5
Failure to Deflate	5	5
Material Split, Cut or Torn	5	5
Unsealed Device Packaging	5	5
Fluid/Blood Leak	5	5
Separation Failure	5	5
Defective Component	4	4
Difficult to Insert	4	4
Contamination /Decontamination Problem	4	4
Material Too Soft/Flexible	4	4
Unintended Deflation	4	4
Physical Resistance/Sticking	3	3
Material Integrity Problem	3	4
Device Damaged Prior to Use	3	3
Device Contaminated During Manufacture or Shipping	3	3
Detachment of Device or Device Component	3	3
Failure to Unfold or Unwrap	3	3
Shipping Damage or Problem	2	2
Positioning Failure	2	2
No Flow	2	2
Device Markings/Labelling Problem	2	2
Deformation Due to Compressive Stress	2	2
Device Contamination with Chemical or Other Material	2	2
Packaging Problem	2	2
Complete Blockage	2	2
Incomplete or Inadequate Connection	2	2
Burst Container or Vessel	1	1
Disconnection	1	1
Delivered as Unsterile Product	1	1
Material Too Rigid or Stiff	1	1
Contamination	1	1
Defective Device	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
Decreased Respiratory Rate	4	4
Pain	4	4
Ventilator Dependent	4	4
No Information	4	4
No Known Impact Or Consequence To Patient	3	3
Hemorrhage/Bleeding	3	3
Pulmonary Embolism	2	2
Aspiration Pneumonitis	2	2
Unintended Extubation	2	2
Exsanguination	2	2
Airway Obstruction	2	2
Obstruction/Occlusion	2	2
Death	1	1
Hypoventilation	1	1
Laceration(s)	1	1
Patient Problem/Medical Problem	1	1
Septic Shock	1	1
Low Blood Pressure/ Hypotension	1	1
Sepsis	1	1
Respiratory Insufficiency	1	1
Foreign Body In Patient	1	1
Respiratory Failure	1	1
Unspecified Kidney or Urinary Problem	1	1
Bradycardia	1	1
Unspecified Respiratory Problem	1	2
Decreased Peak Expiratory Flow rate	1	1