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	70	70
Leak/Splash	51	51
Delivered as Unsterile Product	49	49
Break	42	43
Overheating of Device	42	42
Suction Failure	40	40
Device Contaminated During Manufacture or Shipping	39	39
Temperature Problem	35	35
Suction Problem	35	35
Fluid/Blood Leak	34	34
Detachment of Device or Device Component	30	30
Decrease in Pressure	29	29
Crack	28	28
Packaging Problem	27	27
Mechanical Problem	26	26
Material Fragmentation	18	18
Contamination	17	17
Contamination /Decontamination Problem	14	14
Obstruction of Flow	14	14
Device Contamination with Chemical or Other Material	14	14
Noise, Audible	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
Complete Blockage	7	7
Excessive Heating	7	7
Corroded	7	7
Defective Device	5	5
Fracture	4	4
Nonstandard Device	4	4
Self-Activation or Keying	4	4
Key or Button Unresponsive/not Working	4	4
Sparking	4	4
Sharp Edges	3	3
Material Separation	3	3
No Apparent Adverse Event	3	3
Battery Problem	3	3
Shipping Damage or Problem	3	3
No Flow	3	3
Therapeutic or Diagnostic Output Failure	3	3
Device Remains Activated	3	3
Defective Component	3	3
Failure to Shut Off	3	3
Insufficient Information	3	3
Collapse	3	3
Material Integrity Problem	2	2
Fumes or Vapors	2	2
Continuous Firing	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	483	484
Insufficient Information	90	90
No Known Impact Or Consequence To Patient	20	20
Foreign Body In Patient	13	13
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
Cyst(s)	1	1
Chemical Exposure	1	1
Deposits	1	1
Discomfort	1	1
Pain	1	1
Dysphagia/ Odynophagia	1	1
Cough	1	1
Ulcer	1	3
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