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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
Regulation Description Inflatable tracheal tube cuff.
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 1
IDMED
  SUBSTANTIALLY EQUIVALENT 1
KAL-MED, LLC
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI LONGMANN TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K242642  CuffTrek

MDR Year MDR Reports MDR Events
2020 1 1
2021 9 18
2022 4 4
2023 51 52
2024 133 134
2025 46 46
2026 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 133 142
Unable to Obtain Readings 33 33
Loose or Intermittent Connection 20 20
Break 19 19
Electrical /Electronic Property Problem 12 12
Insufficient Information 9 9
Pressure Problem 6 15
Mechanical Jam 3 3
Crack 3 3
Display or Visual Feedback Problem 3 3
No Audible Alarm 3 3
Charging Problem 3 3
No Device Output 2 2
Gas Output Problem 2 2
Component Missing 2 2
Infusion or Flow Problem 2 2
Use of Incorrect Control/Treatment Settings 2 2
Fluid/Blood Leak 1 1
No Flow 1 1
Complete Loss of Power 1 1
Human-Device Interface Problem 1 10
Appropriate Term/Code Not Available 1 1
Fracture 1 1
Installation-Related Problem 1 2
Product Quality Problem 1 10
Device Emits Odor 1 1
Material Deformation 1 1
Inflation Problem 1 1
Decrease in Pressure 1 1
Use of Device Problem 1 1
Battery Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Inadequate Instructions for Healthcare Professional 1 1
Deflation Problem 1 1
Positioning Problem 1 1
Defective Component 1 1
Failure to Zero 1 2
Smoking 1 1
Unintended Deflation 1 1
Incomplete or Inadequate Connection 1 1
Mechanical Problem 1 1
Material Split, Cut or Torn 1 1
Failure to Read Input Signal 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 239 241
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

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