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TPLC
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show TPLC since
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Device
regulator, vacuum
Product Code
KDP
Regulation Number
880.6740
Device Class
2
MDR Year
MDR Reports
MDR Events
2014
18
18
2015
13
13
2016
18
18
2017
5
5
2018
1
1
2019
3
3
2022
2
2
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device Operates Differently Than Expected
15
15
Material Integrity Problem
13
13
Break
13
13
Suction Problem
7
7
Torn Material
4
4
Device Inoperable
4
4
Unstable
4
4
Leak/Splash
3
3
Crack
2
2
Defective Device
2
2
Noise, Audible
2
2
Failure to Cycle
2
2
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Component Incompatible
1
1
Self-Activation or Keying
1
1
Loose or Intermittent Connection
1
1
Increase in Suction
1
1
Device Slipped
1
1
Sparking
1
1
Mechanical Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Contamination
1
1
Failure to Power Up
1
1
Calibration Problem
1
1
Device Handling Problem
1
1
Use of Incorrect Control/Treatment Settings
1
1
Material Separation
1
1
Incorrect Measurement
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
26
26
No Patient Involvement
22
22
No Information
5
5
Respiratory Arrest
2
2
No Consequences Or Impact To Patient
2
2
Death
1
1
Nausea
1
1
No Clinical Signs, Symptoms or Conditions
1
1
Vomiting
1
1
Insufficient Information
1
1
Tissue Damage
1
1
Hemorrhage/Bleeding
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ohio Medical Corporation
II
Jul-10-2018
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