TPLC - Total Product Life Cycle

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Device	stimulator, nerve, peripheral, electric
Regulation Description	Electrical peripheral nerve stimulator.
Product Code	KOI
Regulation Number	868.2775
Device Class	2

Premarket Reviews
Manufacturer	Decision
BLINK DEVICE COMPANY
	SUBSTANTIALLY EQUIVALENT	1
IDMED
	SUBSTANTIALLY EQUIVALENT	1
1. K243339 WiTOF
MIPM MAMMENDORFER INSTITUT FÜR PHYSIK UND MEDIZIN GMBH
	SUBSTANTIALLY EQUIVALENT	2
NERBIO MEDICAL SOFTWARE PLATFORMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
NIHON KOHDEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
SENZIME AB
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Use of Device Problem	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Over-Sensing	2	2
Excess Flow or Over-Infusion	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Unexpected Therapeutic Results	2	2
Thermal Decomposition of Device	1	1
No Audible Alarm	1	1
Alarm Not Visible	1	1
Communication or Transmission Problem	1	1
Output Problem	1	1
Signal Artifact/Noise	1	1
Patient Device Interaction Problem	1	1
Energy Output Problem	1	1
Overheating of Device	1	1
Erratic Results	1	1
Protective Measures Problem	1	1
Material Integrity Problem	1	1
Break	1	1
Material Split, Cut or Torn	1	1
Device Handling Problem	1	1
Gas Output Problem	1	1
Insufficient Information	1	1
No Device Output	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Insufficient Information	5	5
No Clinical Signs, Symptoms or Conditions	4	4
No Code Available	2	2
Muscle Weakness	2	2
Burn(s)	2	2
Oversedation	2	2
Skin Tears	2	2
Superficial (First Degree) Burn	1	1
Respiratory Acidosis	1	1
No Known Impact Or Consequence To Patient	1	1
Paralysis	1	1
Pain	1	1
Unspecified Tissue Injury	1	1
Partial thickness (Second Degree) Burn	1	1