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TPLC
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show TPLC since
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2024
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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
1. K191858
Pylant Monitor
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
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