TPLC - Total Product Life Cycle

show TPLC since

Device	bed, patient rotation, powered
Regulation Description	Powered patient rotation bed.
Product Code	IKZ
Regulation Number	890.5225
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	24	24
Electrical /Electronic Property Problem	10	12
Positioning Problem	7	7
Patient Device Interaction Problem	5	6
Sharp Edges	3	3
No Apparent Adverse Event	2	2
Insufficient Information	2	2
Material Too Soft/Flexible	2	2
Material Too Rigid or Stiff	1	2
Difficult or Delayed Positioning	1	1
Output Problem	1	1
Pressure Problem	1	1
Unintended Movement	1	1
Physical Resistance/Sticking	1	1
Intermittent Energy Output	1	1
Activation Problem	1	1
Inflation Problem	1	1
Unintended System Motion	1	1
Defective Device	1	1
Patient-Device Incompatibility	1	1
Detachment of Device or Device Component	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pressure Sores	27	27
No Clinical Signs, Symptoms or Conditions	17	19
Insufficient Information	5	5
Pain	2	2
Physical Entrapment	2	2
Hyperemia	2	2
Skin Disorders	1	2
Skin Discoloration	1	2
Rash	1	1
Discomfort	1	1
Scar Tissue	1	1
Fall	1	1
Muscle/Tendon Damage	1	1
Unspecified Tissue Injury	1	1
Unintended Extubation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Kinsman Enterprises Inc	II	Oct-21-2021
2	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021