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
Device Slipped	143	278
Material Integrity Problem	104	104
Delamination	104	104
Use of Device Problem	62	62
Break	56	56
Fracture	52	52
Adverse Event Without Identified Device or Use Problem	51	51
Maintenance Does Not Comply To Manufacturers Recommendations	47	47
Nonstandard Device	34	34
Material Deformation	33	33
Device Operates Differently Than Expected	30	30
Increase in Pressure	26	26
Insufficient Information	22	22
Detachment of Device or Device Component	10	10
Device Misassembled During Manufacturing /Shipping	9	9
Leak/Splash	7	7
Patient Device Interaction Problem	7	7
Deflation Problem	6	6
Unintended Movement	6	6
Patient-Device Incompatibility	6	6
Degraded	6	6
Inflation Problem	6	6
No Apparent Adverse Event	5	5
Device-Device Incompatibility	4	4
Decrease in Pressure	4	4
Component Falling	4	4
Structural Problem	3	3
Material Split, Cut or Torn	3	3
Pressure Problem	3	3
Moisture Damage	3	3
Device Emits Odor	3	3
Installation-Related Problem	3	3
Mechanics Altered	2	2
Material Discolored	2	2
Contamination /Decontamination Problem	2	2
Unclear Information	2	2
Detachment Of Device Component	2	2
Appropriate Term/Code Not Available	2	2
Difficult or Delayed Positioning	2	2
Defective Component	2	2
Torn Material	2	2
Mechanical Problem	2	2
Device Contamination with Body Fluid	2	2
Use of Incorrect Control/Treatment Settings	1	1
Air Leak	1	1
Noise, Audible	1	1
Shipping Damage or Problem	1	1
Fluid/Blood Leak	1	1
Electrical /Electronic Property Problem	1	1
Loose or Intermittent Connection	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	348	348
No Consequences Or Impact To Patient	69	127
Pressure Sores	66	66
Fall	59	70
No Clinical Signs, Symptoms or Conditions	22	62
No Information	21	21
Injury	13	13
Discomfort	12	12
Tissue Breakdown	10	10
Pain	10	10
Insufficient Information	8	8
Tissue Damage	7	7
Death	6	6
Skin Tears	5	5
No Patient Involvement	5	41
Physical Entrapment	4	4
Ulcer	3	3
Skin Discoloration	3	3
Exposure to Body Fluids	3	3
Bruise/Contusion	2	2
Skin Irritation	2	2
No Code Available	2	2
Bone Fracture(s)	2	2
Dysphagia/ Odynophagia	2	2
Cardiogenic Shock	2	2
Tinnitus	1	1
Headache	1	1
Fainting	1	1
Bacterial Infection	1	1
Asphyxia	1	1
Dyspnea	1	1
Laceration(s)	1	1
Numbness	1	1
Eye Burn	1	1
Head Injury	1	1
Muscle Weakness	1	1
Hematoma	1	1
Nausea	1	1
Respiratory Distress	1	1
Hip Fracture	1	1
Hypersensitivity/Allergic reaction	1	1
Tingling	1	1
Stroke/CVA	1	1
Fracture, Arm	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Arjo Hospital Equipment AB	II	Mar-06-2015
2	EHOB, Inc.	II	Jun-24-2021
3	EHOB, Inc.	II	Mar-09-2020
4	Joerns Healthcare	II	May-30-2018
5	KCI USA, Inc.	II	Jan-25-2010
6	Stryker Medical Division of Stryker Corporation	II	Aug-06-2021
7	Stryker Medical Division of Stryker Corporation	II	Sep-25-2020
8	Stryker Medical Division of Stryker Corporation	II	May-23-2011