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TPLC
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show TPLC since
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2024
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Device
cable, electrode
Product Code
IKD
Regulation Number
890.1175
Device Class
2
MDR Year
MDR Reports
MDR Events
2019
4
4
2020
7
7
2021
11
11
2022
17
17
2023
5
5
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
12
12
Overheating of Device
4
4
Mechanical Problem
3
3
Melted
2
2
Thermal Decomposition of Device
2
2
Failure to Conduct
2
2
False Positive Result
2
2
Connection Problem
2
2
Detachment of Device or Device Component
1
1
Gas/Air Leak
1
1
Adverse Event Without Identified Device or Use Problem
1
1
Output Problem
1
1
Insufficient Information
1
1
Material Split, Cut or Torn
1
1
Product Quality Problem
1
1
Fire
1
1
Labelling, Instructions for Use or Training Problem
1
1
Disconnection
1
1
Erratic or Intermittent Display
1
1
Circuit Failure
1
1
Device Alarm System
1
1
Break
1
1
Misassembled
1
1
Nonstandard Device
1
1
Defibrillation/Stimulation Problem
1
1
High Readings
1
1
Low Readings
1
1
Communication or Transmission Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
29
29
No Consequences Or Impact To Patient
5
5
Insufficient Information
4
4
No Known Impact Or Consequence To Patient
3
3
No Patient Involvement
2
2
No Code Available
1
1
Limb Fracture
1
1
Hypoxia
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Ad-Tech Medical Instrument Corporation
II
Sep-20-2021
2
GE Healthcare, LLC
III
Mar-26-2019
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