TPLC - Total Product Life Cycle

• Device: cuff, tracheal tube, inflatable
• 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
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2019	2	2
2020	1	1
2021	9	9
2022	4	4
2023	51	51
2024	20	20

Device Problems	MDRs with this Device Problem	Events in those MDRs
Gas/Air Leak	49	49
Unable to Obtain Readings	16	16
Insufficient Information	7	7
Pressure Problem	3	3
Display or Visual Feedback Problem	3	3
Material Deformation	2	2
Mechanical Jam	2	2
Positioning Problem	1	1
Deflation Problem	1	1
Material Split, Cut or Torn	1	1
Incomplete or Inadequate Connection	1	1
Unintended Deflation	1	1
Fluid/Blood Leak	1	1
Fracture	1	1
Inflation Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Leak/Splash	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
Human-Device Interface Problem	1	1
Infusion or Flow Problem	1	1
Installation-Related Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	76	76
Insufficient Information	4	4
Cardiac Arrest	2	2
Hypoxia	2	2
Low Oxygen Saturation	2	2
Bronchospasm	1	1
No Information	1	1
Respiratory Insufficiency	1	1
Ventilator Dependent	1	1

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