TPLC - Total Product Life Cycle

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Device	equipment, laboratory, general purpose, labeled or promoted for a specific medical use
Regulation Description	General purpose laboratory equipment 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
Incorrect, Inadequate or Imprecise Result or Readings	1251	1252
Break	7	8
Device Markings/Labelling Problem	5	5
Overheating of Device	5	5
Improper or Incorrect Procedure or Method	4	4
Unintended Movement	4	4
Thermal Decomposition of Device	4	4
Incorrect Measurement	3	5
Low Test Results	3	4
Electrical /Electronic Property Problem	3	3
Mechanical Problem	3	4
Use of Device Problem	3	3
Appropriate Term/Code Not Available	3	3
Leak/Splash	2	2
Communication or Transmission Problem	2	2
Intermittent Communication Failure	2	2
Problem with Software Installation	2	2
Detachment of Device or Device Component	1	1
Self-Activation or Keying	1	1
Inaccurate Information	1	1
Corroded	1	1
Physical Resistance/Sticking	1	1
Delivered as Unsterile Product	1	1
Device Handling Problem	1	1
False Positive Result	1	2
Installation-Related Problem	1	1
Unintended System Motion	1	1
Power Problem	1	1
Non Reproducible Results	1	1
Device Reprocessing Problem	1	1
Missing Test Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1292	1298
No Known Impact Or Consequence To Patient	7	7
No Consequences Or Impact To Patient	4	4
No Patient Involvement	3	3
Insufficient Information	2	2
Burn(s)	2	2
Laceration(s)	2	2
Hypersensitivity/Allergic reaction	1	1