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	1253	1254
Break	7	8
Device Markings/Labelling Problem	5	5
Unintended Movement	4	4
Incorrect Measurement	3	5
Improper or Incorrect Procedure or Method	3	3
Low Test Results	3	4
Leak/Splash	2	2
Communication or Transmission Problem	2	2
Use of Device Problem	2	2
High Test Results	2	2
Appropriate Term/Code Not Available	2	2
Electrical /Electronic Property Problem	2	2
Intermittent Communication Failure	2	2
Mechanical Problem	1	2
Physical Resistance/Sticking	1	1
Non Reproducible Results	1	1
Defective Device	1	1
No Fail-Safe Mechanism	1	1
Fail-Safe Problem	1	1
Backflow	1	1
Missing Test Results	1	1
Delivered as Unsterile Product	1	1
Device Handling Problem	1	1
Detachment of Device or Device Component	1	1
Installation-Related Problem	1	1
Power Problem	1	1
Protective Measures Problem	1	1
Device Reprocessing Problem	1	1
Unintended System Motion	1	1
Inaccurate Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1293	1298
Laceration(s)	3	3
Burn(s)	2	2
Insufficient Information	2	2
Hypersensitivity/Allergic reaction	1	1
No Consequences Or Impact To Patient	1	1