TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Fluid/Blood Leak	243	243
Leak/Splash	62	62
Material Separation	24	24
Device Operates Differently Than Expected	7	7
Incomplete or Inadequate Connection	6	6
No Device Output	6	6
No Display/Image	5	5
Device Displays Incorrect Message	5	5
Fracture	4	4
Crack	3	3
Loose or Intermittent Connection	3	3
Incorrect, Inadequate or Imprecise Result or Readings	2	2
Pressure Problem	1	1
Reset Problem	1	1
Break	1	1
Device Operational Issue	1	1
Device Fell	1	1
No Audible Alarm	1	1
Air Leak	1	1
Failure to Power Up	1	1
Use of Device Problem	1	1
Improper Flow or Infusion	1	1
Decrease in Pressure	1	1
Infusion or Flow Problem	1	1
Adverse Event Without Identified Device or Use Problem	1	1
Missing Test Results	1	1
No Audible Prompt/Feedback	1	1
Data Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Application Network Problem	1	1
Connection Problem	1	1
Device Inoperable	1	1
Computer System Security Problem	1	1
Display or Visual Feedback Problem	1	1
Detachment Of Device Component	1	1
Failure to Discharge	1	1
Inadequate User Interface	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	135	135
Blood Loss	90	90
No Clinical Signs, Symptoms or Conditions	79	79
No Known Impact Or Consequence To Patient	39	39
No Patient Involvement	30	30
Hemorrhage/Bleeding	9	9
Low Blood Pressure/ Hypotension	3	3
Air Embolism	1	1
High Blood Pressure/ Hypertension	1	1
Death	1	1
Exposure to Body Fluids	1	1
Tissue Damage	1	1
Erosion	1	1
Thromboembolism	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Argon Medical Devices, Inc	II	Jul-06-2012