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TPLC
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show TPLC since
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2024
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Device
mask, oxygen
Product Code
BYG
Regulation Number
868.5580
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
29
29
2020
6
6
2021
12
12
2022
18
18
2023
4
4
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Inflation Problem
9
9
Detachment of Device or Device Component
8
8
Disconnection
6
6
Material Deformation
5
5
Loose or Intermittent Connection
4
4
Break
3
3
Fracture
2
2
Defective Component
2
2
Material Integrity Problem
2
2
Material Twisted/Bent
2
2
Material Separation
2
2
Failure to Unfold or Unwrap
2
2
Patient Device Interaction Problem
2
2
Material Split, Cut or Torn
2
2
Contamination /Decontamination Problem
2
2
Failure to Seal
2
2
Incomplete or Inadequate Connection
1
1
Material Too Soft/Flexible
1
1
Fitting Problem
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Output Problem
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Device Markings/Labelling Problem
1
1
Difficult to Open or Close
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Dislodged or Dislocated
1
1
Electrical Shorting
1
1
Improper Flow or Infusion
1
1
Infusion or Flow Problem
1
1
Component Missing
1
1
Inaccurate Delivery
1
1
Obstruction of Flow
1
1
Failure to Calibrate
1
1
Patient-Device Incompatibility
1
1
Delivered as Unsterile Product
1
1
Unsealed Device Packaging
1
1
Material Puncture/Hole
1
1
Device Alarm System
1
1
Labelling, Instructions for Use or Training Problem
1
1
Leak/Splash
1
1
Use of Incorrect Control/Treatment Settings
1
1
Display or Visual Feedback Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
20
20
No Consequences Or Impact To Patient
16
16
Low Oxygen Saturation
9
9
No Known Impact Or Consequence To Patient
9
9
Insufficient Information
4
4
Tissue Breakdown
3
3
No Patient Involvement
2
2
Skin Inflammation/ Irritation
2
2
Respiratory Insufficiency
2
2
Blister
1
1
Confusion/ Disorientation
1
1
Lethargy
1
1
Discomfort
1
1
Complaint, Ill-Defined
1
1
Loss of consciousness
1
1
Choking
1
1
Abnormal Blood Gases
1
1
Corneal Abrasion
1
1
Cyanosis
1
1
Dyspnea
1
1
Hypoxia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
POM Medical LLC
II
Oct-31-2019
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