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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
  1.  K191858  Pylant Monitor
SHANGHAI LONGMANN TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

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 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Gas/Air Leak 132 141
Unable to Obtain Readings 33 33
Loose or Intermittent Connection 20 20
Break 18 18
Electrical /Electronic Property Problem 12 12
Insufficient Information 9 9
Pressure Problem 4 13
Charging Problem 3 3
Mechanical Jam 3 3
No Audible Alarm 3 3
Display or Visual Feedback Problem 3 3
Infusion or Flow Problem 2 2
Component Missing 2 2
No Device Output 2 2
Gas Output Problem 2 2
Battery Problem 1 1
Human-Device Interface Problem 1 10
Installation-Related Problem 1 2
Failure to Read Input Signal 1 1
Smoking 1 1
Use of Device Problem 1 1
Failure to Zero 1 2
Defective Component 1 1
Material Deformation 1 1
No Flow 1 1
Positioning Problem 1 1
Appropriate Term/Code Not Available 1 1
Material Split, Cut or Torn 1 1
Incomplete or Inadequate Connection 1 1
Unintended Deflation 1 1
Inflation Problem 1 1
Inadequate Instructions for Healthcare Professional 1 1
Mechanical Problem 1 1
Device Emits Odor 1 1
Product Quality Problem 1 10
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Crack 1 1
Deflation Problem 1 1
Fluid/Blood Leak 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 235 237
Insufficient Information 6 6
Cardiac Arrest 2 11
Hypoxia 2 11
No Information 1 1
Bronchospasm 1 1
Respiratory Insufficiency 1 1
Ventilator Dependent 1 10
Unintended Extubation 1 1

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