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	2
1. K220854 TrachCuff Cuff Controller
2. K261499 TrachFlush
BIOVO TECHNOLOGIES , LTD.
	SUBSTANTIALLY EQUIVALENT	1
COVIDIEN, LLC
	SUBSTANTIALLY EQUIVALENT	1
HOSPITECH RESPIRATION , LTD.
	SUBSTANTIALLY EQUIVALENT	1
IDMED
	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	132	132
Unable to Obtain Readings	33	33
Loose or Intermittent Connection	20	20
Break	19	19
Electrical /Electronic Property Problem	12	12
Insufficient Device Problem Information	9	9
Use of Incorrect Control/Treatment Settings	4	4
Display or Visual Feedback Problem	4	4
Pressure Problem	3	3
No Audible Alarm	3	3
Charging Problem	3	3
Gas Output Problem	3	3
Mechanical Jam	3	3
Crack	2	2
Component Missing	2	2
Infusion or Flow Problem	2	2
No Device Output	2	2
Leak/Splash	1	1
Failure to Read Input Signal	1	1
Material Split, Cut or Torn	1	1
Unexpected Shutdown	1	1
Mechanical Problem	1	1
Unintended Deflation	1	1
Smoking	1	1
Failure to Zero	1	2
Defective Component	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Battery Problem	1	1
Use of Device Problem	1	1
Decrease in Pressure	1	1
Inflation Problem	1	1
Device Emits Odor	1	1
Installation-Related Problem	1	2
Appropriate Device Problem Term/Code Not Available	1	1
Fracture	1	1
Complete Loss of Power	1	1
Improper or Incorrect Procedure or Method	1	1
No Flow	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	245	247
Insufficient Information	6	6
Cardiac Arrest	3	12
Hypoxia	2	11
Unintended Extubation	2	2
Pneumothorax	1	1
No Information	1	1
Aspiration/Inhalation	1	1
Vomiting	1	1
Bronchospasm	1	1
Respiratory Insufficiency	1	1
Ventilator Dependent	1	10
Low Oxygen Saturation	1	1