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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 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 79 79
Insufficient Information 28 28
Break 27 27
Moisture Damage 21 21
Difficult to Open or Close 17 17
Use of Device Problem 17 17
Device Operates Differently Than Expected 15 15
Electrical /Electronic Property Problem 11 11
Device Inoperable 9 9
Device Handling Problem 9 9
Defective Component 8 8
Device Displays Incorrect Message 8 8
Contamination 8 8
Mechanical Problem 7 7
Fluid/Blood Leak 7 7
Unintended System Motion 6 6
Material Discolored 6 6
Improper or Incorrect Procedure or Method 6 6
Sticking 5 5
Patient Device Interaction Problem 5 5
Unintended Movement 5 5
Torn Material 4 4
Device Slipped 4 4
No Display/Image 4 4
Patient-Device Incompatibility 4 4
Cut In Material 4 4
Human Factors Issue 4 4
Positioning Problem 4 4
Deflation Problem 4 4
Detachment Of Device Component 4 4
Bent 3 3
Difficult To Position 3 3
Material Integrity Problem 3 3
Device Issue 3 3
Detachment of Device or Device Component 3 3
Sharp Edges 3 3
No Apparent Adverse Event 3 3
Material Too Soft/Flexible 3 3
Sparking 2 2
Human-Device Interface Problem 2 2
Device Operational Issue 2 2
Device Dislodged or Dislocated 2 2
Defective Device 2 2
Scratched Material 2 2
Mechanical Jam 2 2
Material Puncture/Hole 2 2
Product Quality Problem 2 2
Hole In Material 2 2
Inflation Problem 2 2
Loose or Intermittent Connection 2 2
Misconnection 2 2
Low Audible Alarm 2 2
Device Alarm System 2 2
Difficult or Delayed Positioning 2 2
Crack 2 2
Application Interface Becomes Non-Functional Or Program Exits Abnormally 2 2
Disconnection 1 1
Unintended Ejection 1 1
Fire 1 1
False Alarm 1 1
Component Falling 1 1
Thermal Decomposition of Device 1 1
Device Emits Odor 1 1
Self-Activation or Keying 1 1
No Device Output 1 1
Loss of Power 1 1
Failure to Power Up 1 1
Device Difficult to Program or Calibrate 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Operating System Becomes Nonfunctional 1 1
Output Problem 1 1
Pressure Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Protrusion/Extrusion 1 1
Separation Failure 1 1
Smoking 1 1
Device Stops Intermittently 1 1
Inadequate or Insufficient Training 1 1
Physical Resistance/Sticking 1 1
Noise, Audible 1 1
Appropriate Term/Code Not Available 1 1
Intermittent Energy Output 1 1
Activation Problem 1 1
Unclear Information 1 1
Misassembly During Maintenance/Repair 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 79 79
Pressure Sores 68 68
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
Skin Erosion 3 3
Cardiac Arrest 3 3
Cardiopulmonary Arrest 2 2
Tachycardia 2 2
Hyperemia 2 2
Hypoventilation 2 2
Physical Entrapment 2 2
Complaint, Ill-Defined 2 2
No Code Available 2 2
Loss Of Pulse 2 2
No Patient Involvement 2 2
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Unspecified Tissue Injury 1 1
Unintended Extubation 1 1
Loss of Vision 1 1
Electric Shock 1 1
Extubate 1 1
Failure of Implant 1 1
Laceration(s) 1 1
Necrosis 1 1
Scar Tissue 1 1
Contusion 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Bone Fracture(s) 1 1
Dyspnea 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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