TPLC - Total Product Life Cycle

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Device	tube, tracheal/bronchial, differential ventilation (w/wo connector)
Product Code	CBI
Regulation Number	868.5740
Device Class	2

Premarket Reviews
Manufacturer	Decision
AMBU A/S
	SUBSTANTIALLY EQUIVALENT	1
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
DAIKEN MEDICAL CO, LTD.
	SUBSTANTIALLY EQUIVALENT	1
ETVIEW LTD.
	SUBSTANTIALLY EQUIVALENT	4
EZ-BLOCKER B.V.
	SUBSTANTIALLY EQUIVALENT	1
HENAN TUOREN MEDICAL DEVICE CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
HYTEK MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INSUNG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PULMONX CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
PULMONX, INC.
	SUBSTANTIALLY EQUIVALENT	2
SHENZHEN INSIGHTERS MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
WELL LEAD INSTRUMENTS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	217	217
Inflation Problem	100	100
Leak/Splash	95	95
Gas/Air Leak	76	76
Deflation Problem	24	24
Crack	16	16
Material Deformation	13	13
Output Problem	13	13
Fracture	13	13
Mechanical Problem	13	13
Material Separation	12	12
Air Leak	12	12
Component Missing	12	12
Material Twisted/Bent	11	11
Material Rupture	9	9
Device Operates Differently Than Expected	8	8
Material Split, Cut or Torn	8	8
Infusion or Flow Problem	7	7
Ejection Problem	7	7
Use of Device Problem	7	7
Connection Problem	6	6
Obstruction of Flow	6	6
Material Puncture/Hole	6	6
Separation Failure	6	6
Device Dislodged or Dislocated	6	6
Fitting Problem	6	6
Hole In Material	6	6
Failure to Deflate	5	5
Unsealed Device Packaging	5	5
Defective Component	5	5
Kinked	5	5
Incomplete or Missing Packaging	5	5
Device Markings/Labelling Problem	5	5
Difficult to Insert	5	5
Structural Problem	4	4
Contamination /Decontamination Problem	4	4
Decrease in Pressure	4	4
Material Integrity Problem	4	4
Disconnection	4	4
Device Damaged Prior to Use	4	4
Suction Problem	4	4
Device Contaminated During Manufacture or Shipping	4	4
Packaging Problem	4	4
Unintended Deflation	4	4
Device Contamination with Chemical or Other Material	4	4
Bent	3	3
Detachment of Device or Device Component	3	3
Complete Blockage	3	3
Device Alarm System	3	3
Physical Resistance/Sticking	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	366	366
No Consequences Or Impact To Patient	140	140
No Known Impact Or Consequence To Patient	101	101
No Patient Involvement	69	69
Insufficient Information	50	50
Extubate	24	24
No Information	13	13
Low Oxygen Saturation	13	13
Respiratory Failure	9	9
Hypoxia	7	7
No Code Available	4	4
Hemorrhage/Bleeding	4	4
Ventilator Dependent	4	4
Decreased Respiratory Rate	4	4
Foreign Body In Patient	3	3
Pain	3	3
Patient Problem/Medical Problem	2	2
Death	2	2
Pneumothorax	2	2
Therapy/non-surgical treatment, additional	2	2
Exsanguination	2	2
Obstruction/Occlusion	2	2
Shock	2	2
Airway Obstruction	2	2
Unintended Extubation	2	2
Pulmonary Embolism	2	2
Device Embedded In Tissue or Plaque	2	2
Bleeding	1	1
Sepsis	1	1
Decreased Peak Expiratory Flow rate	1	1
Edema	1	1
Chest Pain	1	1
Septic Shock	1	1
Laceration(s)	1	1
Unspecified Kidney or Urinary Problem	1	1
Bradycardia	1	1
Surgical procedure aborted/stopped	1	1
Unspecified Respiratory Problem	1	1
Respiratory Insufficiency	1	1
Low Blood Pressure/ Hypotension	1	1