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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bed, patient rotation, powered
Product CodeIKZ
Regulation Number 890.5225
Device Class 2

MDR Year MDR Reports MDR Events
2014 80 80
2015 40 40
2016 26 26
2017 35 35
2018 28 28
2019 27 27
2020 29 29
2021 11 11
2022 6 6
2023 20 20
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 80 80
Insufficient Information 28 28
Break 27 27
Moisture Damage 21 21
Use of Device Problem 17 17
Difficult to Open or Close 17 17
Device Operates Differently Than Expected 15 15
Electrical /Electronic Property Problem 11 11
Device Handling Problem 9 9
Device Inoperable 9 9
Device Displays Incorrect Message 8 8
Defective Component 8 8
Contamination 8 8
Mechanical Problem 7 7
Fluid/Blood Leak 7 7
Improper or Incorrect Procedure or Method 6 6
Unintended System Motion 6 6
Patient Device Interaction Problem 6 6
Material Discolored 6 6
Unintended Movement 5 5
Sticking 5 5
Device Slipped 4 4
Cut In Material 4 4
No Display/Image 4 4
Torn Material 4 4
Patient-Device Incompatibility 4 4
Positioning Problem 4 4
No Apparent Adverse Event 4 4
Deflation Problem 4 4
Human Factors Issue 4 4
Detachment Of Device Component 4 4
Inflation Problem 3 3
Bent 3 3
Device Issue 3 3
Material Too Soft/Flexible 3 3
Detachment of Device or Device Component 3 3
Difficult To Position 3 3
Sharp Edges 3 3
Material Integrity Problem 3 3
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Sparking 2 2
Misconnection 2 2
Low Audible Alarm 2 2
Difficult or Delayed Positioning 2 2
Device Dislodged or Dislocated 2 2
Hole In Material 2 2
Crack 2 2
Product Quality Problem 2 2
Scratched Material 2 2
Defective Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 79 79
Pressure Sores 70 70
No Consequences Or Impact To Patient 44 44
Injury 20 20
Death 17 17
Tissue Damage 12 12
No Clinical Signs, Symptoms or Conditions 12 12
Fall 11 11
Tissue Breakdown 10 10
Low Oxygen Saturation 9 9
Pain 9 9
No Information 8 8
Insufficient Information 4 4
Skin Tears 3 3
Cardiac Arrest 3 3
Skin Erosion 3 3
Hyperemia 2 2
Tachycardia 2 2
Physical Entrapment 2 2
Cardiopulmonary Arrest 2 2
No Patient Involvement 2 2
Loss Of Pulse 2 2
No Code Available 2 2
Hypoventilation 2 2
Complaint, Ill-Defined 2 2
Foreign Body In Patient 1 1
Skin Discoloration 1 1
Dyspnea 1 1
Contusion 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Bradycardia 1 1
Skin Disorders 1 1
Bone Fracture(s) 1 1
Unspecified Tissue Injury 1 1
Necrosis 1 1
Loss of Vision 1 1
Failure of Implant 1 1
Electric Shock 1 1
Bacterial Infection 1 1
Extubate 1 1
Unintended Extubation 1 1
Patient Problem/Medical Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arjo Hospital Equipment AB II Feb-27-2015
2 ArjoHuntleigh Inc. II Feb-04-2014
3 Arjohuntleigh Magog II Feb-05-2019
4 KCI USA, Inc. II May-10-2011
5 KCI USA, Inc. II Dec-13-2010
6 Kinsman Enterprises Inc II Oct-21-2021
7 Stryker Medical Division of Stryker Corporation II Aug-06-2021
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