TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	758	758
Loose or Intermittent Connection	196	196
Display or Visual Feedback Problem	152	152
Break	85	85
Incorrect, Inadequate or Imprecise Result or Readings	43	43
Device Contamination with Chemical or Other Material	42	42
Inflation Problem	21	21
Unsealed Device Packaging	17	17
Material Separation	17	17
Tear, Rip or Hole in Device Packaging	15	15
Physical Resistance/Sticking	14	14
Packaging Problem	11	11
Appropriate Term/Code Not Available	10	10
Improper or Incorrect Procedure or Method	10	10
Deflation Problem	9	9
Defective Device	7	7
Device Contaminated During Manufacture or Shipping	7	7
Material Integrity Problem	7	7
Product Quality Problem	6	6
Shipping Damage or Problem	6	6
Mechanical Problem	6	6
Noise, Audible	6	6
Pressure Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Contamination	5	5
Crack	4	4
Detachment of Device or Device Component	4	4
Suction Problem	4	4
Unstable	3	3
Failure to Zero	3	3
Insufficient Information	2	2
Contamination /Decontamination Problem	2	2
Connection Problem	2	2
Difficult to Remove	2	2
Obstruction of Flow	2	2
Device Sensing Problem	2	2
Difficult to Open or Remove Packaging Material	2	2
Mechanical Jam	2	2
Device Dislodged or Dislocated	1	1
Low Readings	1	1
Deformation Due to Compressive Stress	1	1
Device Damaged Prior to Use	1	1
Retraction Problem	1	1
Material Rupture	1	1
Use of Device Problem	1	1
Fluid/Blood Leak	1	1
Fracture	1	1
No Device Output	1	1
No Pressure	1	1
Output Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	879	879
No Consequences Or Impact To Patient	267	267
No Patient Involvement	18	18
No Known Impact Or Consequence To Patient	13	13
Insufficient Information	12	12
Air Embolism	7	7
Arrhythmia	3	3
Cardiac Arrest	3	3
Low Blood Pressure/ Hypotension	3	3
Vascular Dissection	3	3
Death	2	2
Bradycardia	2	2
Hemorrhage/Bleeding	1	1
Laceration(s)	1	1
Perforation	1	1
Ventricular Fibrillation	1	1
Thrombosis/Thrombus	1	1