TPLC - Total Product Life Cycle

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Device	equipment, laboratory, general purpose, labeled or promoted for a specific medical use
Product Code	LXG
Regulation Number	862.2050
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	8	8
Mechanical Problem	5	5
Overheating of Device	5	5
Use of Device Problem	5	5
Incorrect, Inadequate or Imprecise Result or Readings	4	4
Thermal Decomposition of Device	4	4
Device Markings/Labelling Problem	4	4
Unintended Movement	4	4
Appropriate Term/Code Not Available	3	3
Electrical /Electronic Property Problem	3	3
Leak/Splash	3	3
Incorrect Measurement	3	3
Improper or Incorrect Procedure or Method	3	3
Patient Data Problem	2	2
Defective Device	2	2
Communication or Transmission Problem	2	2
Problem with Software Installation	2	2
Non Reproducible Results	2	2
Inaccurate Information	1	1
Protective Measures Problem	1	1
Temperature Problem	1	1
Defective Alarm	1	1
Detachment of Device or Device Component	1	1
Device Displays Incorrect Message	1	1
Chemical Problem	1	1
Device Handling Problem	1	1
Missing Test Results	1	1
Physical Resistance/Sticking	1	1
Difficult to Open or Close	1	1
Failure to Auto Stop	1	1
Device Contamination with Chemical or Other Material	1	1
Installation-Related Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Output Problem	1	1
Power Problem	1	1
Low Test Results	1	1
Self-Activation or Keying	1	1
Delivered as Unsterile Product	1	1
Device Emits Odor	1	1
Unintended System Motion	1	1
Fluid/Blood Leak	1	1
Device Reprocessing Problem	1	1
Corroded	1	1
Crack	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	34	34
No Known Impact Or Consequence To Patient	26	26
No Consequences Or Impact To Patient	7	7
No Patient Involvement	6	6
Laceration(s)	2	2
Insufficient Information	2	2
No Information	1	1
Burn(s)	1	1
Death	1	1
Hypersensitivity/Allergic reaction	1	1