TPLC - Total Product Life Cycle

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

Premarket Reviews
Manufacturer	Decision
AW TECHNOLOGIES APS
	SUBSTANTIALLY EQUIVALENT	1
BIOVO TECHNOLOGIES LTD.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN LLC
	SUBSTANTIALLY EQUIVALENT	1
HOSPITECH RESPIRATION LTD.
	SUBSTANTIALLY EQUIVALENT	1
KAL-MED LLC
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI LONGMANN TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	113	113
Unable to Obtain Readings	33	33
Loose or Intermittent Connection	20	20
Break	17	17
Insufficient Information	8	8
Pressure Problem	3	3
No Audible Alarm	3	3
Charging Problem	3	3
Display or Visual Feedback Problem	3	3
Component Missing	2	2
Gas Output Problem	2	2
Mechanical Jam	2	2
Material Split, Cut or Torn	1	1
Mechanical Problem	1	1
Incomplete or Inadequate Connection	1	1
Unintended Deflation	1	1
Smoking	1	1
Failure to Zero	1	1
Defective Component	1	1
Positioning Problem	1	1
Deflation Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Battery Problem	1	1
Use of Device Problem	1	1
Infusion or Flow Problem	1	1
Inflation Problem	1	1
Material Deformation	1	1
Device Emits Odor	1	1
Product Quality Problem	1	1
Installation-Related Problem	1	1
Fracture	1	1
Appropriate Term/Code Not Available	1	1
Human-Device Interface Problem	1	1
Fluid/Blood Leak	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	202	202
Insufficient Information	4	4
Cardiac Arrest	2	2
Hypoxia	2	2
No Information	1	1
Bronchospasm	1	1
Respiratory Insufficiency	1	1
Ventilator Dependent	1	1
Unintended Extubation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Covidien	II	Sep-29-2023