TPLC - Total Product Life Cycle

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Device	cuff, tracheal tube, inflatable
Product Code	BSK
Regulation Number	868.5750
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARM MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
AW TECHNOLOGIES APS
	SUBSTANTIALLY EQUIVALENT	1
BIOVO TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN LLC
	SUBSTANTIALLY EQUIVALENT	1
HAMILTON MEDICAL AG
	SUBSTANTIALLY EQUIVALENT	1
HOSPITECH RESPIRATION LTD.
	SUBSTANTIALLY EQUIVALENT	4
INSTRUMENTATION INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
JOAN SPIEGEL, MD
	SUBSTANTIALLY EQUIVALENT	1
KAL-MED LLC
	SUBSTANTIALLY EQUIVALENT	1
SPIRITUS TECHNOLOGIES LLC
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TRACOE MEDICAL GMBH
	SUBSTANTIALLY EQUIVALENT	2
VENNER MEDICAL (SINGAPORE) PTE LTD
	SUBSTANTIALLY EQUIVALENT	1
VENTLAB CORP.
	SUBSTANTIALLY EQUIVALENT	1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	49	49
Unable to Obtain Readings	16	16
Insufficient Information	8	8
Pressure Problem	3	3
Material Deformation	3	3
Display or Visual Feedback Problem	3	3
Detachment Of Device Component	3	3
Inflation Problem	3	3
Deflation Problem	2	2
Disconnection	2	2
Loose or Intermittent Connection	2	2
Mechanical Jam	2	2
Connection Problem	2	2
Human-Device Interface Problem	2	2
Infusion or Flow Problem	1	1
Installation-Related Problem	1	1
Device Dislodged or Dislocated	1	1
Fail-Safe Problem	1	1
Positioning Problem	1	1
Air Leak	1	1
Material Split, Cut or Torn	1	1
Incomplete or Inadequate Connection	1	1
Unintended Deflation	1	1
Mechanical Problem	1	1
Device Emits Odor	1	1
Product Quality Problem	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Use of Device Problem	1	1
Failure to Zero	1	1
Component Missing	1	1
Inadequate Instructions for Healthcare Professional	1	1
Leak/Splash	1	1
Entrapment of Device	1	1
Fluid/Blood Leak	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	76	76
Extubate	8	8
Insufficient Information	4	4
Hypoxia	3	3
Cardiac Arrest	2	2
Low Oxygen Saturation	2	2
No Known Impact Or Consequence To Patient	2	2
No Information	1	1
Respiratory Insufficiency	1	1
Increased Respiratory Rate	1	1
Bronchospasm	1	1
Nasal Obstruction	1	1
Death	1	1
Dyspnea	1	1
Complaint, Ill-Defined	1	1
Ventilator Dependent	1	1