TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Detachment of Device or Device Component	119	119
Misconnection	72	72
Loss of or Failure to Bond	37	37
Adverse Event Without Identified Device or Use Problem	19	19
Disconnection	16	16
Material Twisted/Bent	16	16
Difficult to Open or Close	16	16
Break	13	13
Defective Component	9	9
Loose or Intermittent Connection	9	9
Contamination /Decontamination Problem	8	8
Malposition of Device	8	8
Material Separation	5	5
Crack	5	5
Detachment Of Device Component	5	5
Mechanical Problem	5	5
Product Quality Problem	4	4
Difficult to Remove	4	4
Fluid/Blood Leak	4	4
Therapeutic or Diagnostic Output Failure	3	3
Defective Device	3	3
Component Missing	3	3
Incorrect, Inadequate or Imprecise Result or Readings	3	3
Patient-Device Incompatibility	3	3
Component Falling	3	3
Device Tipped Over	3	3
Degraded	2	2
Material Deformation	2	2
Device Contamination with Chemical or Other Material	1	1
Contamination of Device Ingredient or Reagent	1	1
Incorrect Measurement	1	1
Activation Failure	1	1
Failure To Run On AC/DC	1	1
Infusion or Flow Problem	1	1
Structural Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Device Fell	1	1
Unintended Movement	1	1
Insufficient Information	1	1
Physical Resistance/Sticking	1	1
Fire	1	1
Unintended Collision	1	1
Improper or Incorrect Procedure or Method	1	1
Unintended Arm Motion	1	1
Electromagnetic Interference	1	1
Connection Problem	1	1
Device Operates Differently Than Expected	1	1
Appropriate Term/Code Not Available	1	1
Electromagnetic Compatibility Problem	1	1
Delivered as Unsterile Product	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	163	163
No Consequences Or Impact To Patient	140	140
No Known Impact Or Consequence To Patient	20	20
No Patient Involvement	10	10
Ulcer	9	9
Insufficient Information	6	6
Erythema	4	4
Foreign Body Reaction	3	3
Skin Irritation	2	2
No Information	2	2
Patient Problem/Medical Problem	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Unspecified Infection	1	1
Tingling	1	1
Electric Shock	1	1
Complaint, Ill-Defined	1	1
Death	1	1
Skin Inflammation/ Irritation	1	1
Head Injury	1	1
Inflammation	1	1
Abrasion	1	1
No Patient involvement	1	1
Purulent Discharge	1	1
Itching Sensation	1	1
Blister	1	1
Injury	1	1
Foreign Body In Patient	1	1
Swelling	1	1
Laceration(s)	1	1
Physical Entrapment	1	1
Reaction	1	1
Contact Dermatitis	1	1
Skin Tears	1	1
Bruise/Contusion	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	EKOS Corporation	II	Sep-27-2016
2	Firefly Medical, Inc.	II	Sep-07-2017
3	Firefly Medical, Inc.	II	Dec-15-2016
4	Ohmeda Medical	II	Mar-26-2018
5	Stryker Medical Division of Stryker Corporation	II	Nov-30-2015