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	33	168
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
Material Split, Cut or Torn	3	3
Inflation Problem	3	3
Unclear Information	2	2
Difficult or Delayed Positioning	2	2
Collapse	1	1
Unintended Movement	1	1
Device Fell	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	1
Sharp Edges	1	1
Use of Incorrect Control/Treatment Settings	1	1
Device Emits Odor	1	1
Detachment of Device or Device Component	1	1
Fungus in Device Environment	1	1
Material Too Soft/Flexible	1	1
Electrical /Electronic Property Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pressure Sores	42	42
Fall	41	52
No Consequences Or Impact To Patient	30	88
No Clinical Signs, Symptoms or Conditions	22	62
Insufficient Information	8	8
Pain	7	7
Injury	5	5
No Patient Involvement	4	40
Tissue Damage	3	3
Death	2	2
Cardiogenic Shock	2	2
Physical Entrapment	2	2
Dysphagia/ Odynophagia	2	2
Ulcer	2	2
Skin Tears	2	2
Hypersensitivity/Allergic reaction	1	1
Hip Fracture	1	1
Nausea	1	1
Skin Irritation	1	1
Head Injury	1	1
Muscle Weakness	1	1
Eye Burn	1	1
Skin Discoloration	1	1
No Known Impact Or Consequence To Patient	1	1
Asphyxia	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