TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Leak/Splash	1070	1070
Loose or Intermittent Connection	209	209
Display or Visual Feedback Problem	171	171
Break	113	113
Physical Resistance/Sticking	48	48
Incorrect, Inadequate or Imprecise Result or Readings	47	48
Device Contamination with Chemical or Other Material	43	43
Inflation Problem	24	24
Material Separation	20	20
Unsealed Device Packaging	17	17
Tear, Rip or Hole in Device Packaging	15	15
Improper or Incorrect Procedure or Method	14	14
Packaging Problem	11	11
Appropriate Term/Code Not Available	10	10
Deflation Problem	9	9
Noise, Audible	8	8
Product Quality Problem	8	8
Material Integrity Problem	8	8
Device Contaminated During Manufacture or Shipping	7	7
Defective Device	7	7
Adverse Event Without Identified Device or Use Problem	7	7
Shipping Damage or Problem	6	6
Crack	6	6
Mechanical Problem	6	6
Contamination	5	5
Pressure Problem	5	5
Detachment of Device or Device Component	4	4
Suction Problem	4	4
Obstruction of Flow	3	3
Failure to Zero	3	3
Unstable	3	3
Contamination /Decontamination Problem	2	2
Difficult to Remove	2	2
Insufficient Information	2	2
Device Sensing Problem	2	2
Difficult to Open or Remove Packaging Material	2	2
Connection Problem	2	2
Mechanical Jam	2	2
No Pressure	1	1
Use of Device Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Rupture	1	1
Device Damaged Prior to Use	1	1
Output Problem	1	1
Retraction Problem	1	1
Low Readings	1	1
Fracture	1	1
Device Dislodged or Dislocated	1	1
Material Split, Cut or Torn	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1227	1228
No Consequences Or Impact To Patient	267	267
No Patient Involvement	18	18
Insufficient Information	14	14
No Known Impact Or Consequence To Patient	13	13
Air Embolism	7	7
Arrhythmia	3	3
Vascular Dissection	3	3
Cardiac Arrest	3	3
Laceration(s)	3	3
Hemorrhage/Bleeding	3	3
Low Blood Pressure/ Hypotension	3	3
Death	2	2
Bradycardia	2	2
Perforation	1	1
Ventricular Fibrillation	1	1
Thrombosis/Thrombus	1	1
Perforation of Vessels	1	1