TPLC - Total Product Life Cycle

show TPLC since

Device	apparatus, suction, operating-room, wall vacuum powered
Product Code	GCX
Regulation Number	880.6740
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Delivered as Unsterile Product	40	40
Break	37	37
Suction Failure	36	36
Suction Problem	28	28
Packaging Problem	27	27
Detachment of Device or Device Component	23	23
Leak/Splash	16	16
Material Fragmentation	16	16
Device Contamination with Chemical or Other Material	14	14
Obstruction of Flow	14	14
Crack	13	13
Contamination	13	13
Contamination /Decontamination Problem	13	13
Mechanical Problem	12	12
Failure to Eject	12	12
Device Contaminated During Manufacture or Shipping	11	11
Fluid/Blood Leak	9	9
Material Puncture/Hole	9	9
Decrease in Suction	8	8
Complete Blockage	7	7
Corroded	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Fracture	4	4
No Flow	3	3
Collapse	3	3
Insufficient Information	3	3
Material Separation	3	3
Sharp Edges	3	3
Shipping Damage or Problem	3	3
Temperature Problem	2	2
Nonstandard Device	2	2
Failure to Conduct	2	2
Use of Device Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Material Integrity Problem	2	2
Smoking	2	2
Unsealed Device Packaging	2	2
Output Problem	2	2
Sparking	2	2
Difficult to Remove	1	1
Scratched Material	1	1
Degraded	1	1
Deflation Problem	1	1
Battery Problem	1	1
Material Discolored	1	1
Component Missing	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Improper Flow or Infusion	1	1
Defective Device	1	1
Particulates	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	241	241
Insufficient Information	61	61
No Known Impact Or Consequence To Patient	20	20
Foreign Body In Patient	10	10
No Consequences Or Impact To Patient	7	7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Laceration(s)	5	5
Hemorrhage/Bleeding	4	4
Pneumothorax	3	3
No Patient Involvement	3	3
Death	2	2
No Code Available	2	2
Cardiac Arrest	2	2
Exposure to Body Fluids	2	2
Pulmonary Edema	2	2
Hemothorax	2	2
Device Embedded In Tissue or Plaque	2	2
Pleural Empyema	1	1
Deposits	1	1
Discomfort	1	1
Ulcer	1	1
Unspecified Heart Problem	1	1
Bacterial Infection	1	1
Airway Obstruction	1	1
Low Blood Pressure/ Hypotension	1	1
Liver Laceration(s)	1	1