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
1. K201026 sOLVe Tube
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	84	84
Leak/Splash	76	76
Inflation Problem	70	70
Deflation Problem	28	28
Crack	11	11
Fracture	10	10
Material Deformation	10	10
Material Rupture	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
Failure to Deflate	5	5
Material Split, Cut or Torn	5	5
Incomplete or Missing Packaging	5	5
Separation Failure	5	5
Unsealed Device Packaging	5	5
Obstruction of Flow	5	5
Fluid/Blood Leak	4	4
Material Too Soft/Flexible	4	4
Difficult to Insert	4	4
Contamination /Decontamination Problem	4	4
Defective Component	4	4
Unintended Deflation	4	4
Material Integrity Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Device Damaged Prior to Use	3	3
Detachment of Device or Device Component	3	3
Failure to Unfold or Unwrap	3	3
Physical Resistance/Sticking	3	3
No Flow	2	2
Shipping Damage or Problem	2	2
Deformation Due to Compressive Stress	2	2
Positioning Failure	2	2
Complete Blockage	2	2
Device Contamination with Chemical or Other Material	2	2
Incomplete or Inadequate Connection	2	2
Packaging Problem	2	2
Disconnection	1	1
Failure to Disconnect	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Connection Problem	1	1
Appropriate Term/Code Not Available	1	1
Burst Container or Vessel	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	450	450
Insufficient Information	53	53
No Consequences Or Impact To Patient	42	42
No Patient Involvement	25	25
Low Oxygen Saturation	14	14
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	1
Respiratory Insufficiency	1	1
Low Blood Pressure/ Hypotension	1	1
Respiratory Failure	1	1