TPLC - Total Product Life Cycle

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

MDR Year	MDR Reports	MDR Events
2014	206	206
2015	74	74
2016	62	62
2017	27	27
2018	130	130
2019	45	102
2020	16	54
2021	13	49
2022	44	44
2023	23	23
2024	5	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Slipped	142	277
Delamination	104	104
Material Integrity Problem	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
Patient Device Interaction Problem	7	7
Leak/Splash	7	7
Inflation Problem	6	6
Deflation Problem	6	6
Degraded	6	6
Unintended Movement	6	6
Patient-Device Incompatibility	6	6
No Apparent Adverse Event	5	5
Decrease in Pressure	4	4
Device-Device Incompatibility	4	4
Component Falling	4	4
Moisture Damage	3	3
Structural Problem	3	3
Installation-Related Problem	3	3
Pressure Problem	3	3
Material Split, Cut or Torn	3	3
Unclear Information	2	2
Torn Material	2	2
Appropriate Term/Code Not Available	2	2
Mechanics Altered	2	2
Device Contamination with Body Fluid	2	2
Contamination /Decontamination Problem	2	2
Mechanical Problem	2	2
Device Emits Odor	2	2
Defective Component	2	2
Detachment Of Device Component	2	2
Difficult or Delayed Positioning	2	2
Material Discolored	2	2
Material Disintegration	1	1
Electrical /Electronic Property Problem	1	1
Filling Problem	1	1
Fluid/Blood Leak	1	1
Air Leak	1	1
Collapse	1	1
Contamination	1	1
Use of Incorrect Control/Treatment Settings	1	1
Kinked	1	1
Component Missing	1	1
Fungus in Device Environment	1	1
Unstable	1	1
Loose or Intermittent Connection	1	1
Material Separation	1	1
Shipping Damage or Problem	1	1
Inadequacy of Device Shape and/or Size	1	1
Inadequate Instructions for Non-Healthcare Professional	1	1
Moisture or Humidity Problem	1	1
Naturally Worn	1	1
Material Protrusion/Extrusion	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Noise, Audible	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
No Known Impact Or Consequence To Patient	348	348
No Consequences Or Impact To Patient	69	127
Pressure Sores	66	66
Fall	57	68
No Information	21	21
No Clinical Signs, Symptoms or Conditions	19	59
Injury	13	13
Discomfort	12	12
Tissue Breakdown	10	10
Pain	10	10
Tissue Damage	7	7
Death	6	6
Skin Tears	5	5
Insufficient Information	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
Bone Fracture(s)	2	2
Skin Irritation	2	2
Cardiogenic Shock	2	2
No Code Available	2	2
Tingling	1	1
Tinnitus	1	1
Respiratory Distress	1	1
Bacterial Infection	1	1
Eye Burn	1	1
Fracture, Arm	1	1
Numbness	1	1
Head Injury	1	1
Headache	1	1
Hematoma	1	1
Hypersensitivity/Allergic reaction	1	1
Laceration(s)	1	1
Muscle Weakness	1	1
Nausea	1	1
Stroke/CVA	1	1
Asphyxia	1	1
Dysphagia/ Odynophagia	1	1
Dyspnea	1	1
Fainting	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