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TPLC
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show TPLC since
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Device
bed, patient rotation, powered
Regulation Description
Powered patient rotation bed.
Product Code
IKZ
Regulation Number
890.5225
Device Class
2
MDR Year
MDR Reports
MDR Events
2020
29
29
2021
11
11
2022
6
6
2023
20
20
2024
7
7
2025
3
5
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
35
35
Electrical /Electronic Property Problem
9
11
Patient Device Interaction Problem
6
6
No Apparent Adverse Event
4
4
Insufficient Information
3
3
Use of Device Problem
3
3
Sharp Edges
3
3
Material Too Soft/Flexible
3
3
Defective Component
2
2
Difficult or Delayed Positioning
2
2
Device Slipped
1
1
Operating System Becomes Nonfunctional
1
1
Pressure Problem
1
1
No Display/Image
1
1
Mechanical Problem
1
1
Output Problem
1
1
Physical Resistance/Sticking
1
1
Activation Problem
1
1
Intermittent Energy Output
1
1
Patient-Device Incompatibility
1
1
Defective Device
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
Improper or Incorrect Procedure or Method
1
1
Mechanical Jam
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Pressure Sores
34
34
No Clinical Signs, Symptoms or Conditions
17
19
Insufficient Information
5
5
Injury
3
3
No Known Impact Or Consequence To Patient
2
2
Pain
2
2
Physical Entrapment
2
2
No Consequences Or Impact To Patient
2
2
Hyperemia
2
2
Tissue Breakdown
2
2
No Code Available
1
1
Bone Fracture(s)
1
1
Skin Disorders
1
1
Skin Discoloration
1
1
Fall
1
1
Laceration(s)
1
1
Scar Tissue
1
1
Unspecified Tissue Injury
1
1
Extubate
1
1
Low Oxygen Saturation
1
1
Unintended Extubation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Kinsman Enterprises Inc
II
Oct-21-2021
2
Stryker Medical Division of Stryker Corporation
II
Aug-06-2021
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