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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cuff, tracheal tube, inflatable
Product CodeBSK
Regulation Number 868.5750
Device Class 2


Premarket Reviews
ManufacturerDecision
AW TECHNOLOGIES APS
  SUBSTANTIALLY EQUIVALENT 1
BIOVO TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 1
COVIDIEN LLC
  SUBSTANTIALLY EQUIVALENT 1
HOSPITECH RESPIRATION LTD.
  SUBSTANTIALLY EQUIVALENT 2
KAL-MED LLC
  SUBSTANTIALLY EQUIVALENT 1
TIANJIN MEDIS MEDICAL DEVICE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VORTRAN MEDICAL TECHNOLOGY 1, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 4 4
2019 2 2
2020 1 1
2021 9 9
2022 4 4
2023 30 30

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 20 20
Unable to Obtain Readings 7 7
Inflation Problem 3 3
Pressure Problem 3 3
Material Deformation 2 2
Mechanical Jam 2 2
Display or Visual Feedback Problem 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 1 1
Device Emits Odor 1 1
Product Quality Problem 1 1
Fluid/Blood Leak 1 1
Inadequate Instructions for Healthcare Professional 1 1
Leak/Splash 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Use of Device Problem 1 1
Component Missing 1 1
Connection Problem 1 1
Fail-Safe Problem 1 1
Human-Device Interface Problem 1 1
Infusion or Flow Problem 1 1
Installation-Related Problem 1 1
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
Insufficient Information 4 4
Extubate 3 3
Low Oxygen Saturation 2 2
Cardiac Arrest 2 2
Hypoxia 2 2
Ventilator Dependent 1 1
Death 1 1
Dyspnea 1 1
Increased Respiratory Rate 1 1
Bronchospasm 1 1
No Information 1 1
Respiratory Insufficiency 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Hamilton Medical, Inc. II Jan-12-2018
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