TPLC - Total Product Life Cycle

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Device	mattress, flotation therapy, non-powered
Product Code	IKY
Regulation Number	880.5150
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	37	37
Device Slipped	31	162
Increase in Pressure	26	26
Use of Device Problem	9	9
Insufficient Information	7	7
Patient Device Interaction Problem	7	7
No Apparent Adverse Event	5	5
Device-Device Incompatibility	4	4
Patient-Device Incompatibility	4	4
Pressure Problem	3	3
Inflation Problem	3	3
Material Split, Cut or Torn	3	3
Unclear Information	2	2
Difficult or Delayed Positioning	2	2
Electrical /Electronic Property Problem	1	1
Collapse	1	1
Use of Incorrect Control/Treatment Settings	1	1
Degraded	1	1
Fungus in Device Environment	1	1
Unintended Movement	1	1
Contamination /Decontamination Problem	1	1
Detachment of Device or Device Component	1	1
Material Too Soft/Flexible	1	1
Sharp Edges	1	1
Device Fell	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pressure Sores	42	42
Fall	39	50
No Consequences Or Impact To Patient	30	88
No Clinical Signs, Symptoms or Conditions	18	54
Pain	7	7
Injury	5	5
Insufficient Information	5	5
No Patient Involvement	4	40
Tissue Damage	3	3
Skin Tears	2	2
Cardiogenic Shock	2	2
Ulcer	2	2
Physical Entrapment	2	2
Death	2	2
Dysphagia/ Odynophagia	1	1
Skin Discoloration	1	1
Skin Irritation	1	1
Asphyxia	1	1
Head Injury	1	1
Hypersensitivity/Allergic reaction	1	1
Muscle Weakness	1	1
Nausea	1	1
Eye Burn	1	1
No Known Impact Or Consequence To Patient	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	EHOB, Inc.	II	Jun-24-2021
2	EHOB, Inc.	II	Mar-09-2020
3	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021
4	Stryker Medical Division of Stryker Corporation	II	Sep-25-2020