Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device bed, patient rotation, powered
Product CodeIKZ
Regulation Number 890.5225
Device Class 2

MDR Year MDR Reports MDR Events
2019 27 27
2020 29 29
2021 11 11
2022 6 6
2023 20 20
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 44 44
Difficult to Open or Close 8 8
Electrical /Electronic Property Problem 7 7
Patient Device Interaction Problem 6 6
Use of Device Problem 4 4
No Apparent Adverse Event 4 4
Material Too Soft/Flexible 4 4
Mechanical Problem 3 3
Insufficient Information 3 3
Sharp Edges 3 3
Patient-Device Incompatibility 2 2
Unintended Movement 2 2
Defective Component 2 2
Difficult or Delayed Positioning 2 2
Product Quality Problem 2 2
Mechanical Jam 2 2
Device Slipped 1 1
Operating System Becomes Nonfunctional 1 1
Pressure Problem 1 1
No Display/Image 1 1
Fire 1 1
Output Problem 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1
Device Alarm System 1 1
Intermittent Energy Output 1 1
Unclear Information 1 1
Defective Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Failure to Power Up 1 1
Material Too Rigid or Stiff 1 1
Misassembly During Maintenance/Repair 1 1
Inflation Problem 1 1
Device Difficult to Program or Calibrate 1 1
Detachment of Device or Device Component 1 1
Unintended System Motion 1 1
Human-Device Interface Problem 1 1
Self-Activation or Keying 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pressure Sores 43 43
No Clinical Signs, Symptoms or Conditions 15 15
No Consequences Or Impact To Patient 13 13
No Known Impact Or Consequence To Patient 5 5
Injury 5 5
Insufficient Information 4 4
Pain 2 2
Physical Entrapment 2 2
Tissue Damage 2 2
Hyperemia 2 2
Low Oxygen Saturation 2 2
Tissue Breakdown 2 2
No Code Available 1 1
Necrosis 1 1
Bone Fracture(s) 1 1
Skin Disorders 1 1
Skin Discoloration 1 1
Cardiopulmonary Arrest 1 1
Fall 1 1
Laceration(s) 1 1
Scar Tissue 1 1
Unspecified Tissue Injury 1 1
Extubate 1 1
Unintended Extubation 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arjohuntleigh Magog II Feb-05-2019
2 Kinsman Enterprises Inc II Oct-21-2021
3 Stryker Medical Division of Stryker Corporation II Aug-06-2021
-
-