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	51	51
Delivered as Unsterile Product	45	45
Break	40	40
Suction Failure	38	38
Temperature Problem	31	31
Suction Problem	31	31
Packaging Problem	27	27
Leak/Splash	26	26
Detachment of Device or Device Component	25	25
Fluid/Blood Leak	21	21
Material Fragmentation	17	17
Crack	16	16
Obstruction of Flow	14	14
Device Contamination with Chemical or Other Material	14	14
Mechanical Problem	14	14
Device Contaminated During Manufacture or Shipping	14	14
Contamination	13	13
Contamination /Decontamination Problem	13	13
Failure to Eject	12	12
Material Puncture/Hole	9	9
Pressure Problem	9	9
Adverse Event Without Identified Device or Use Problem	8	8
Decrease in Suction	8	8
Complete Blockage	7	7
Corroded	6	6
Fracture	4	4
Overheating of Device	4	4
Nonstandard Device	3	3
Collapse	3	3
Insufficient Information	3	3
Material Separation	3	3
No Flow	3	3
Sharp Edges	3	3
Therapeutic or Diagnostic Output Failure	3	3
Shipping Damage or Problem	3	3
Noise, Audible	3	3
Power Problem	2	2
Failure to Conduct	2	2
No Apparent Adverse Event	2	2
Device Emits Odor	2	2
Continuous Firing	2	2
Decrease in Pressure	2	2
Use of Device Problem	2	2
Key or Button Unresponsive/not Working	2	2
Sparking	2	2
Entrapment of Device	2	2
Material Integrity Problem	2	2
Output Problem	2	2
Unsealed Device Packaging	2	2
Fumes or Vapors	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	367	367
Insufficient Information	74	74
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
Airway Obstruction	1	1
Low Blood Pressure/ Hypotension	1	1
Liver Laceration(s)	1	1