TPLC - Total Product Life Cycle

• 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