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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
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2024
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Device
stimulator, nerve, peripheral, electric
Product Code
KOI
Regulation Number
868.2775
Device Class
2
Premarket Reviews
Manufacturer
Decision
BLINK DEVICE COMPANY
SUBSTANTIALLY EQUIVALENT
1
BLINK DEVICE CORPORATION
SUBSTANTIALLY EQUIVALENT
1
IDMED
SUBSTANTIALLY EQUIVALENT
1
MIPM MAMMENDORFER INSTITUT FÜR PHYSIK UND MEDIZIN GMBH
SUBSTANTIALLY EQUIVALENT
1
NIHON KOHDEN CORPORATION
SUBSTANTIALLY EQUIVALENT
3
SENZIME AB
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
1
1
2019
4
4
2020
4
4
2021
3
3
2022
4
4
2023
1
1
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Output Problem
3
3
Use of Device Problem
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Over-Sensing
2
2
Unexpected Therapeutic Results
2
2
Overheating of Device
2
2
No Device Output
2
2
Excess Flow or Over-Infusion
2
2
Protective Measures Problem
1
1
Device Handling Problem
1
1
Alarm Not Visible
1
1
Insufficient Information
1
1
Thermal Decomposition of Device
1
1
Failure to Select Signal
1
1
Energy Output Problem
1
1
Smoking
1
1
No Audible Alarm
1
1
Melted
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Insufficient Information
3
3
No Code Available
2
2
Skin Tears
2
2
No Known Impact Or Consequence To Patient
2
2
Muscle Weakness
2
2
Oversedation
2
2
Suffocation
2
2
Respiratory Acidosis
1
1
Apnea
1
1
Burn(s)
1
1
Asphyxia
1
1
Pain
1
1
Paralysis
1
1
Partial thickness (Second Degree) Burn
1
1
Not Applicable
1
1
No Patient Involvement
1
1
Superficial (First Degree) Burn
1
1
No Clinical Signs, Symptoms or Conditions
1
1
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