TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BIO PROTECH, INC.
	SUBSTANTIALLY EQUIVALENT	1
LINA MEDICAL APS
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEGADYNE MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
NORTHGATE TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT	1
SURNIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Difficult or Delayed Activation	50	50
Adverse Event Without Identified Device or Use Problem	9	9
Self-Activation or Keying	9	9
Ventilation Problem in Device Environment	9	9
Noise, Audible	6	6
Electrical Shorting	6	6
Arcing of Electrodes	4	4
Smoking	4	4
Appropriate Term/Code Not Available	4	4
Intermittent Energy Output	4	4
Melted	3	3
Delivered as Unsterile Product	2	2
Device Emits Odor	2	2
Overheating of Device	2	2
Break	2	2
Decrease in Suction	2	2
Fire	2	2
Flaked	2	2
Failure to Calibrate	2	2
Structural Problem	2	2
Defective Device	2	2
Failure to Shut Off	2	2
Therapeutic or Diagnostic Output Failure	2	2
Output Problem	2	2
Activation Failure	2	2
Insufficient Information	1	1
Material Split, Cut or Torn	1	1
Physical Resistance/Sticking	1	1
Unintended Electrical Shock	1	1
Protective Measures Problem	1	1
Temperature Problem	1	1
Arcing at Paddles	1	1
Material Integrity Problem	1	1
Device Displays Incorrect Message	1	1
Sparking	1	1
Communication or Transmission Problem	1	1
Detachment of Device or Device Component	1	1
Electrical Power Problem	1	1
Fumes or Vapors	1	1
Defective Component	1	1
Fluid/Blood Leak	1	1
Unintended Power Up	1	1
Circuit Failure	1	1
Computer Software Problem	1	1
Intermittent Continuity	1	1
Premature Activation	1	1
Device Remains Activated	1	1
Improper or Incorrect Procedure or Method	1	1
Suction Problem	1	1
Material Separation	1	1
Failure to Read Input Signal	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	72	72
Insufficient Information	8	8
No Consequences Or Impact To Patient	6	6
No Patient Involvement	6	6
No Known Impact Or Consequence To Patient	6	6
Partial thickness (Second Degree) Burn	2	2
Hemorrhage/Bleeding	2	2
Rash	1	1
Scar Tissue	1	1
Burning Sensation	1	1
Superficial (First Degree) Burn	1	1
Foreign Body In Patient	1	1
Caustic/Chemical Burns	1	1
Full thickness (Third Degree) Burn	1	1
No Information	1	1
No Code Available	1	1
Blister	1	1
Skin Burning Sensation	1	1
Unspecified Tissue Injury	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Burn(s)	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Mckesson Medical-Surgical Inc. Corporate Office	III	Sep-26-2022