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TPLC
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show TPLC since
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2024
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Device
condenser, heat and moisture (artificial nose)
Product Code
BYD
Regulation Number
868.5375
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
6
6
2015
17
17
2016
18
18
2017
12
12
2018
33
33
2019
15
15
2020
35
35
2021
15
15
2022
32
32
2023
45
45
2024
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Disconnection
37
37
Leak/Splash
32
32
Material Separation
25
25
Defective Device
15
15
Gas/Air Leak
12
12
Loose or Intermittent Connection
10
10
Obstruction of Flow
9
9
Break
8
8
Material Split, Cut or Torn
8
8
Restricted Flow rate
6
6
Fracture
6
6
Detachment of Device or Device Component
4
4
Difficult or Delayed Activation
4
4
Appropriate Term/Code Not Available
4
4
Fitting Problem
4
4
Mechanical Problem
3
3
Contamination /Decontamination Problem
3
3
Tear, Rip or Hole in Device Packaging
3
3
Filtration Problem
3
3
Split
3
3
Material Deformation
3
3
Material Integrity Problem
2
2
Complete Blockage
2
2
Incorrect Measurement
2
2
No Apparent Adverse Event
2
2
Device Operates Differently Than Expected
2
2
Connection Problem
2
2
Use of Device Problem
2
2
Occlusion Within Device
2
2
Stretched
2
2
Contamination
2
2
Gas Output Problem
2
2
Device Contamination with Chemical or Other Material
1
1
Device Dislodged or Dislocated
1
1
Partial Blockage
1
1
Device Sensing Problem
1
1
Suction Problem
1
1
Nonstandard Device
1
1
Device Inoperable
1
1
Flaked
1
1
Insufficient Flow or Under Infusion
1
1
Excess Flow or Over-Infusion
1
1
Structural Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Moisture or Humidity Problem
1
1
Unsealed Device Packaging
1
1
Defective Component
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Sediment, Precipitate Or Deposit In Device Or Device Ingredient
1
1
Insufficient Information
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
74
74
No Consequences Or Impact To Patient
65
65
No Known Impact Or Consequence To Patient
33
33
No Patient Involvement
20
20
Insufficient Information
9
9
No Information
8
8
Low Oxygen Saturation
8
8
Dyspnea
7
7
Cardiac Arrest
5
5
Foreign Body In Patient
4
4
Respiratory Arrest
3
3
Aspiration/Inhalation
3
3
Respiratory Distress
2
2
Malaise
2
2
Hypoxia
2
2
Airway Obstruction
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Cyanosis
1
1
High Blood Pressure/ Hypertension
1
1
Hypoventilation
1
1
Hypersensitivity/Allergic reaction
1
1
Diaphoresis
1
1
Missed Dose
1
1
Skin Inflammation/ Irritation
1
1
Foreign Body Reaction
1
1
Discomfort
1
1
Bradycardia
1
1
Anxiety
1
1
Unspecified Respiratory Problem
1
1
Respiratory Insufficiency
1
1
Ventilator Dependent
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
AB ULAX
II
Oct-06-2020
2
Arc Medical Inc
III
May-09-2015
3
Atos Medical AB
II
May-10-2021
4
TELEFLEX MEDICAL INC
II
May-24-2022
5
Teleflex Medical
II
Aug-29-2016
6
Teleflex Medical
II
Aug-09-2016
7
Teleflex Medical
I
Feb-06-2015
8
Teleflex, Inc.
I
Feb-06-2015
9
Vital Signs Devices, a GE Healthcare Company
I
Jul-30-2011
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