TPLC - Total Product Life Cycle

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Device	apparatus, suction, operating-room, wall vacuum powered
Regulation Description	Vacuum-powered body fluid suction apparatus.
Product Code	GCX
Regulation Number	880.6740
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Smoking	60	60
Delivered as Unsterile Product	46	46
Break	40	40
Suction Failure	38	38
Temperature Problem	35	35
Leak/Splash	32	32
Suction Problem	32	32
Fluid/Blood Leak	28	28
Packaging Problem	27	27
Crack	25	25
Detachment of Device or Device Component	25	25
Overheating of Device	19	19
Material Fragmentation	17	17
Mechanical Problem	16	16
Contamination /Decontamination Problem	14	14
Obstruction of Flow	14	14
Device Contaminated During Manufacture or Shipping	14	14
Device Contamination with Chemical or Other Material	14	14
Contamination	13	13
Failure to Eject	12	12
Pressure Problem	9	9
Material Puncture/Hole	9	9
Decrease in Suction	8	8
Adverse Event Without Identified Device or Use Problem	8	8
Decrease in Pressure	7	7
Complete Blockage	7	7
Corroded	7	7
Noise, Audible	6	6
Fracture	4	4
Defective Device	4	4
Collapse	3	3
Insufficient Information	3	3
Material Separation	3	3
Defective Component	3	3
Sharp Edges	3	3
Excessive Heating	3	3
Nonstandard Device	3	3
Therapeutic or Diagnostic Output Failure	3	3
Self-Activation or Keying	3	3
No Flow	3	3
Shipping Damage or Problem	3	3
No Apparent Adverse Event	2	2
Device Emits Odor	2	2
Failure to Conduct	2	2
Power Problem	2	2
Continuous Firing	2	2
Use of Device Problem	2	2
Key or Button Unresponsive/not Working	2	2
Fumes or Vapors	2	2
Sparking	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	419	419
Insufficient Information	79	79
No Known Impact Or Consequence To Patient	20	20
Foreign Body In Patient	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
No Consequences Or Impact To Patient	7	7
Laceration(s)	5	5
Hemorrhage/Bleeding	4	4
Pneumothorax	3	3
No Patient Involvement	3	3
Pulmonary Edema	3	3
Device Embedded In Tissue or Plaque	3	3
Death	2	2
No Code Available	2	2
Cardiac Arrest	2	2
Exposure to Body Fluids	2	2
Hemothorax	2	2
Pleural Empyema	1	1
Deposits	1	1
Discomfort	1	1
Ulcer	1	1
Unspecified Heart Problem	1	1
Unspecified Respiratory Problem	1	1
Bacterial Infection	1	1
Low Blood Pressure/ Hypotension	1	1
Airway Obstruction	1	1
Liver Laceration(s)	1	1