TPLC - Total Product Life Cycle

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Device	medical computers and software
Product Code	LNX
Device Class	Unclassified

Device Problems	MDRs with this Device Problem	Events in those MDRs
Computer Software Problem	66	66
Application Program Problem	12	12
Programming Issue	12	12
Application Program Problem: Medication Error	9	9
Data Problem	7	7
Patient Data Problem	6	6
Improper or Incorrect Procedure or Method	4	4
Device Operates Differently Than Expected	4	4
Smoking	4	4
Installation-Related Problem	3	3
Device Issue	3	3
Overheating of Device	3	3
Insufficient Information	2	2
Excessive Heating	2	2
Adverse Event Without Identified Device or Use Problem	2	2
Application Interface Becomes Non-Functional Or Program Exits Abnormally	2	2
Loss of Data	1	1
Device Inoperable	1	1
Inappropriate/Inadequate Shock/Stimulation	1	1
Unintended Electrical Shock	1	1
False Reading From Device Non-Compliance	1	1
Human-Device Interface Problem	1	1
Fire	1	1
Data Back-Up Problem	1	1
High Test Results	1	1
No Apparent Adverse Event	1	1
Use of Device Problem	1	1
Unintended Movement	1	1
Alarm Not Visible	1	1
Failure to Back-Up	1	1
Computer Operating System Problem	1	1
Loss of Power	1	1
Inadequate or Insufficient Training	1	1
Human Factors Issue	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Inadequate User Interface	1	1
Crack	1	1
Defective Device	1	1
Device Alarm System	1	1
Mechanics Altered	1	1
Manufacturing, Packaging or Shipping Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	55	55
No Known Impact Or Consequence To Patient	31	31
No Consequences Or Impact To Patient	14	14
No Information	8	8
Overdose	6	6
Complaint, Ill-Defined	3	3
Death	3	3
No Code Available	2	2
Electrolyte Imbalance	2	2
No Patient Involvement	2	2
Underdose	2	2
Patient Problem/Medical Problem	2	2
Electric Shock	2	2
Low Blood Pressure/ Hypotension	2	2
Insufficient Information	2	2
Skin Irritation	1	1
Cognitive Changes	1	1
Respiratory Failure	1	1
Torsades-de-Pointes	1	1
Hematoma	1	1
Hypersensitivity/Allergic reaction	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Missing Value Reason	1	1
Hyperglycemia	1	1
Myocardial Infarction	1	1
Therapeutic Effects, Unexpected	1	1
Unspecified Tissue Injury	1	1
Confusion/ Disorientation	1	1
Missed Dose	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxa Corporation	I	May-25-2012
2	Baxter Corporation Englewood	II	Dec-18-2013
3	SCC Soft Computer	II	Dec-02-2011
4	SCC Soft Computer	II	Dec-02-2011
5	SCC Soft Computer	II	Nov-23-2011
6	SCC Soft Computer	II	Nov-23-2011
7	SCC Soft Computer	II	Jun-30-2011
8	SCC Soft Computer	II	Nov-15-2010
9	SCC Soft Computer	II	Oct-20-2010
10	SCC Soft Computer	II	Oct-20-2010
11	SCC Soft Computer	II	Oct-20-2010
12	SCC Soft Computer	II	Oct-19-2010
13	SCC Soft Computer	II	Oct-19-2010
14	SCC Soft Computer	II	Oct-19-2010
15	SCC Soft Computer	II	Oct-18-2010
16	SCC Soft Computer	II	Oct-15-2010
17	SCC Soft Computer	II	Oct-15-2010
18	Sorin Group Italia S.r.l.	II	Jan-22-2014