TPLC - Total Product Life Cycle

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Device Problems	MDRs with this Device Problem	Events in those MDRs
Deflation Problem	40	40
Unintended Deflation	29	29
Insufficient Information	17	17
Adverse Event Without Identified Device or Use Problem	12	12
Device Contamination with Chemical or Other Material	9	9
Material Integrity Problem	5	5
Appropriate Term/Code Not Available	3	3
Patient-Device Incompatibility	3	3
Contamination	2	2
Fitting Problem	2	2
Nonstandard Device	2	2
Product Quality Problem	2	2
Material Discolored	2	2
Inflation Problem	1	1
Labelling, Instructions for Use or Training Problem	1	1
Inadequate Instructions for Healthcare Professional	1	1
Leak/Splash	1	1
Moisture Damage	1	1
Signal Artifact/Noise	1	1
Burst Container or Vessel	1	1
Detachment Of Device Component	1	1
Component Falling	1	1
Device Slipped	1	1
Inadequate or Insufficient Training	1	1
Improper or Incorrect Procedure or Method	1	1
Off-Label Use	1	1
Positioning Failure	1	1
Defective Device	1	1
Human-Device Interface Problem	1	1
Device Contaminated During Manufacture or Shipping	1	1
Packaging Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	50	50
Insufficient Information	29	29
Pressure Sores	18	18
No Known Impact Or Consequence To Patient	10	10
No Consequences Or Impact To Patient	8	8
Skin Erosion	4	4
Tissue Damage	3	3
Fall	3	3
Injury	3	3
No Patient Involvement	3	3
Tissue Breakdown	3	3
Obstruction/Occlusion	2	2
Confusion/ Disorientation	2	2
Ulcer	2	2
Death	2	2
Intracranial Hemorrhage	2	2
Laceration(s)	2	2
Necrosis	1	1
Pain	1	1
Scar Tissue	1	1
Skin Discoloration	1	1
Ulceration	1	1
Weakness	1	1
Abscess	1	1
Fungal Infection	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Jan-06-2016
2	Childrens Medical Ventures	I	Aug-20-2014
3	EHOB, Inc.	II	Jul-20-2020
4	Philips Medical Systems, Inc.	I	Dec-16-2014