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	55	55
Device Contaminated During Manufacture or Shipping	46	46
Delivered as Unsterile Product	45	45
Break	42	43
Overheating of Device	42	42
Fluid/Blood Leak	39	39
Temperature Problem	35	35
Suction Failure	33	33
Decrease in Pressure	29	29
Detachment of Device or Device Component	28	28
Suction Problem	28	28
Mechanical Problem	23	23
Crack	23	23
Packaging Problem	21	21
Material Fragmentation	20	20
Noise, Audible	14	14
Failure to Eject	12	12
Obstruction of Flow	11	11
Contamination	10	10
Adverse Event Without Identified Device or Use Problem	9	9
Complete Blockage	9	9
Device Contamination with Chemical or Other Material	9	9
Material Puncture/Hole	9	9
Pressure Problem	9	9
Excessive Heating	7	7
Self-Activation or Keying	5	5
Defective Device	5	5
Sparking	4	4
No Apparent Adverse Event	4	4
Corroded	4	4
Fracture	4	4
Battery Problem	4	4
Nonstandard Device	4	4
Key or Button Unresponsive/not Working	4	4
Device Remains Activated	3	3
Material Separation	3	3
Sharp Edges	3	3
Insufficient Information	3	3
Shipping Damage or Problem	3	3
Failure to Shut Off	3	3
Contamination /Decontamination Problem	3	3
Product Quality Problem	2	2
Device Emits Odor	2	2
Fumes or Vapors	2	2
Device-Device Incompatibility	2	2
Decrease in Suction	2	2
Failure to Conduct	2	2
Power Problem	2	2
Material Integrity Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	486	487
Insufficient Information	79	79
Foreign Body In Patient	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	7	7
Laceration(s)	5	5
Hemorrhage/Bleeding	5	5
Pneumothorax	3	3
Pulmonary Edema	3	3
Exposure to Body Fluids	2	2
Dysphagia/ Odynophagia	2	2
Cough	2	2
Hemothorax	2	2
Device Embedded In Tissue or Plaque	2	2
Weight Changes	1	1
Skin Inflammation/ Irritation	1	1
Pleural Empyema	1	1
Cyst(s)	1	1
Inflammation	1	1
Chemical Exposure	1	1
Deposits	1	1
Cardiac Arrest	1	1
Discomfort	1	1
Pain	1	1
Choking	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
Skin Burning Sensation	1	1