TPLC - Total Product Life Cycle

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Device	apparatus, exhaust, surgical
Regulation Description	Air-handling apparatus for a surgical operating room.
Product Code	FYD
Regulation Number	878.5070
Device Class	2

Premarket Reviews
Manufacturer	Decision
CONMED CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
MEDLINE INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEGADYNE MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	61	61
Adverse Event Without Identified Device or Use Problem	11	11
Noise, Audible	9	9
Ventilation Problem in Device Environment	9	9
Appropriate Term/Code Not Available	6	6
Electrical Shorting	6	6
Arcing of Electrodes	5	5
Self-Activation or Keying	5	5
Intermittent Energy Output	4	4
Melted	3	3
Fire	3	3
Smoking	3	3
Flaked	2	2
Failure to Calibrate	2	2
Activation Failure	2	2
Delivered as Unsterile Product	2	2
Structural Problem	2	2
Decrease in Suction	2	2
Therapeutic or Diagnostic Output Failure	2	2
Defective Device	2	2
Break	2	2
Material Integrity Problem	1	1
Defective Component	1	1
Insufficient Information	1	1
Unintended Electrical Shock	1	1
Electrical Power Problem	1	1
Device Emits Odor	1	1
Material Separation	1	1
Failure to Fire	1	1
Detachment of Device or Device Component	1	1
Unintended Power Up	1	1
Physical Resistance/Sticking	1	1
Computer Software Problem	1	1
Output Problem	1	1
Protective Measures Problem	1	1
Communication or Transmission Problem	1	1
Intermittent Continuity	1	1
Suction Problem	1	1
Human-Device Interface Problem	1	1
Overheating of Device	1	1
Material Split, Cut or Torn	1	1
Sparking	1	1
Device Displays Incorrect Message	1	1
Arcing at Paddles	1	1
Fluid/Blood Leak	1	1
Premature Activation	1	1
Fumes or Vapors	1	1
Temperature Problem	1	1
Circuit Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	85	85
Insufficient Information	9	9
Partial thickness (Second Degree) Burn	5	5
No Known Impact Or Consequence To Patient	4	4
Burn(s)	2	2
Hemorrhage/Bleeding	2	2
No Consequences Or Impact To Patient	2	2
Superficial (First Degree) Burn	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
No Information	1	1
Blister	1	1
Rash	1	1
Burning Sensation	1	1
Foreign Body In Patient	1	1
No Patient Involvement	1	1
Scar Tissue	1	1
Unspecified Tissue Injury	1	1
Caustic/Chemical Burns	1	1
Full thickness (Third Degree) Burn	1	1
Skin Burning Sensation	1	1

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