TPLC - Total Product Life Cycle

show TPLC since

Device	system, catheter control, steerable
Product Code	DXX
Regulation Number	870.1290
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Unintended Movement	25	25
Device Displays Incorrect Message	5	5
Component or Accessory Incompatibility	3	3
Device Operates Differently Than Expected	3	3
Component Falling	3	3
Fail-Safe Problem	3	3
Detachment Of Device Component	2	2
Break	2	2
Labelling, Instructions for Use or Training Problem	2	2
Electrical Shorting	2	2
Insufficient Information	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Display or Visual Feedback Problem	2	2
Electrical /Electronic Property Problem	2	2
Device-Device Incompatibility	1	1
Human-Device Interface Problem	1	1
Computer Operating System Problem	1	1
Material Deformation	1	1
Bent	1	1
Power Problem	1	1
Inadequate User Interface	1	1
Communication or Transmission Problem	1	1
Mechanical Problem	1	1
Activation Problem	1	1
Device Operational Issue	1	1
Patient Device Interaction Problem	1	1
Product Quality Problem	1	1
Fail-Safe Did Not Operate	1	1
Thermal Decomposition of Device	1	1
Improper or Incorrect Procedure or Method	1	1
Loss of Power	1	1
Device Issue	1	1
Loss of Data	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	24	24
No Patient Involvement	20	20
No Consequences Or Impact To Patient	14	14
No Clinical Signs, Symptoms or Conditions	4	4
Pericardial Effusion	2	2
Fistula	2	2
Death	1	1
Electric Shock	1	1
Speech Disorder	1	1
No Code Available	1	1
Vascular Dissection	1	1
Movement Disorder	1	1
Paresthesia	1	1
Foreign Body In Patient	1	1
Chest Pain	1	1
Vertigo	1	1
Insufficient Information	1	1