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	25	25
Adverse Event Without Identified Device or Use Problem	21	21
Device Slipped	11	76
Insufficient Device Problem Information	10	10
Use of Device Problem	8	8
Patient Device Interaction Problem	7	7
No Apparent Adverse Event	5	5
Material Deformation	3	3
Patient-Device Incompatibility	3	3
Material Split, Cut or Torn	3	3
Difficult or Delayed Positioning	2	2
Material Puncture/Hole	2	2
Unintended Deflation	2	2
Device-Device Incompatibility	2	2
Fire	2	2
Inflation Problem	2	2
Pressure Problem	2	2
Use of Incorrect Control/Treatment Settings	1	1
Device Emits Odor	1	1
Collapse	1	1
Unclear Information	1	1
Gas/Air Leak	1	1
Electrical /Electronic Property Problem	1	1
Sharp Edges	1	1
Deflation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	407	472
Insufficient Information	69	69
Pressure Sore/Ulcer	40	40
Fall	30	55
Pain	8	8
Exposure to Body Fluids	3	3
Dysphagia/ Odynophagia	2	2
Back pain	2	2
Physical Entrapment	2	2
Burn(s)	2	2
Low Blood Pressure/ Hypotension	1	1
Failure of Implant	1	1
Discomfort	1	1
Nausea	1	1
Hypersensitivity/Allergic reaction	1	1
Pleural Effusion	1	1
Fungal Infection	1	1
Eye Burn	1	1
Dehydration	1	1
Muscle Weakness/Atrophy	1	1
Pneumothorax	1	1
Death	1	1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	1	1
Ulcer	1	1
Head Injury	1	1
Internal Organ Perforation	1	1
Hip Fracture	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