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
Suction Problem	31	31
Temperature 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
Device Contamination with Chemical or Other Material	14	14
Device Contaminated During Manufacture or Shipping	14	14
Obstruction of Flow	14	14
Mechanical Problem	14	14
Contamination /Decontamination Problem	13	13
Contamination	13	13
Failure to Eject	12	12
Pressure Problem	9	9
Material Puncture/Hole	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
Material Separation	3	3
Shipping Damage or Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
No Flow	3	3
Insufficient Information	3	3
Noise, Audible	3	3
Sharp Edges	3	3
Nonstandard Device	3	3
Collapse	3	3
Power Problem	2	2
Output Problem	2	2
No Apparent Adverse Event	2	2
Material Integrity Problem	2	2
Entrapment of Device	2	2
Continuous Firing	2	2
Key or Button Unresponsive/not Working	2	2
Failure to Conduct	2	2
Device Emits Odor	2	2
Unsealed Device Packaging	2	2
Sparking	2	2
Decrease in Pressure	2	2
Use of Device Problem	2	2
Wrong Label	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
No Patient Involvement	3	3
Device Embedded In Tissue or Plaque	3	3
Pneumothorax	3	3
Pulmonary Edema	3	3
Exposure to Body Fluids	2	2
Cardiac Arrest	2	2
Death	2	2
Hemothorax	2	2
No Code Available	2	2
Ulcer	1	1
Discomfort	1	1
Airway Obstruction	1	1
Bacterial Infection	1	1
Deposits	1	1
Low Blood Pressure/ Hypotension	1	1
Unspecified Heart Problem	1	1
Pleural Empyema	1	1
Unspecified Respiratory Problem	1	1
Liver Laceration(s)	1	1