TPLC - Total Product Life Cycle

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

Device Problems	MDRs with this Device Problem	Events in those MDRs
Increase in Pressure	26	26
Adverse Event Without Identified Device or Use Problem	21	21
Device Slipped	11	76
Use of Device Problem	9	9
Insufficient Information	8	8
Patient Device Interaction Problem	5	5
No Apparent Adverse Event	5	5
Material Split, Cut or Torn	3	3
Patient-Device Incompatibility	3	3
Device-Device Incompatibility	2	2
Pressure Problem	2	2
Fire	2	2
Difficult or Delayed Positioning	2	2
Inflation Problem	2	2
Device Contamination with Body Fluid	1	1
Crack	1	1
Collapse	1	1
Unclear Information	1	1
Unintended Deflation	1	1
Deflation Problem	1	1
Contamination /Decontamination Problem	1	1
Degraded	1	1
Gas/Air Leak	1	1
Sharp Edges	1	1
Use of Incorrect Control/Treatment Settings	1	1
Material Deformation	1	1
Device Emits Odor	1	1
Fungus in Device Environment	1	1
Electrical /Electronic Property Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	404	469
Insufficient Information	69	69
Pressure Sores	35	35
Fall	30	55
Pain	8	8
Exposure to Body Fluids	3	3
Burn(s)	2	2
Physical Entrapment	2	2
Dysphagia/ Odynophagia	2	2
Death	1	1
Hypersensitivity/Allergic reaction	1	1
Pneumothorax	1	1
Hip Fracture	1	1
Failure of Implant	1	1
Nausea	1	1
Fungal Infection	1	1
Head Injury	1	1
Muscle Weakness	1	1
Eye Burn	1	1
Pleural Effusion	1	1
Discomfort	1	1
Ulcer	1	1
Low Blood Pressure/ Hypotension	1	1
Internal Organ Perforation	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	EHOB, Inc.	II	Jun-24-2021
2	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021