TPLC - Total Product Life Cycle

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Device	clinical sample concentrator
Product Code	JJH
Regulation Number	862.2310
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Suction Failure	21	21
Unintended Movement	10	10
False Positive Result	10	10
Contamination	9	9
Fluid/Blood Leak	9	9
Leak/Splash	6	6
Contamination /Decontamination Problem	4	4
Contamination of Device Ingredient or Reagent	4	4
Improper or Incorrect Procedure or Method	4	4
Low Sensing Threshold	4	4
Defective Component	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Use of Device Problem	3	3
Pressure Problem	2	2
False Negative Result	2	2
Mechanical Problem	2	2
Device Fell	2	2
Failure to Transmit Record	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Human-Device Interface Problem	2	2
Electrical /Electronic Property Problem	2	2
Failure to Read Input Signal	1	1
Break	1	1
Device Damaged Prior to Use	1	1
Short Fill	1	1
Microbial Contamination of Device	1	1
Degraded	1	1
Unable to Obtain Readings	1	1
Positioning Failure	1	1
Failure to Align	1	1
Failure to Back-Up	1	1
Mechanics Altered	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	85	85
No Known Impact Or Consequence To Patient	7	7
Misdiagnosis	3	3
Abrasion	3	3
Chemical Exposure	3	3
Injury	2	2
No Patient Involvement	2	2
Nausea	1	1
Dizziness	1	1
Bone Fracture(s)	1	1
Exposure to Body Fluids	1	1
Insufficient Information	1	1
Laceration(s)	1	1
No Consequences Or Impact To Patient	1	1