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TPLC
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show TPLC since
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Device
bed, flotation therapy, powered
Product Code
IOQ
Regulation Number
890.5170
Device Class
2
MDR Year
MDR Reports
MDR Events
2018
20
20
2019
4
4
2020
9
9
2021
56
56
2022
22
22
2023
97
97
Device Problems
MDRs with this Device Problem
Events in those MDRs
Unintended Movement
31
31
Use of Device Problem
28
28
Pressure Problem
21
21
Inflation Problem
20
20
Insufficient Information
16
16
Material Split, Cut or Torn
16
16
Appropriate Term/Code Not Available
11
11
Mechanical Problem
11
11
Adverse Event Without Identified Device or Use Problem
8
8
Sparking
8
8
Activation Problem
8
8
Component or Accessory Incompatibility
7
7
Defective Alarm
7
7
No Audible Alarm
5
5
Decrease in Pressure
5
5
Break
4
4
Scratched Material
4
4
Material Deformation
4
4
Defective Device
3
3
Gas/Air Leak
3
3
Electrical /Electronic Property Problem
3
3
Patient Device Interaction Problem
3
3
Fire
2
2
Material Frayed
2
2
Collapse
2
2
Use of Incorrect Control/Treatment Settings
2
2
Deflation Problem
2
2
Positioning Problem
2
2
Device Alarm System
2
2
Patient-Device Incompatibility
1
1
Battery Problem
1
1
Material Protrusion/Extrusion
1
1
Mechanical Jam
1
1
Naturally Worn
1
1
Power Problem
1
1
Temperature Problem
1
1
No Apparent Adverse Event
1
1
Grounding Malfunction
1
1
Increase in Pressure
1
1
Material Puncture/Hole
1
1
Device Slipped
1
1
Smoking
1
1
Misassembled
1
1
Improper or Incorrect Procedure or Method
1
1
Sharp Edges
1
1
Complete Loss of Power
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
87
87
Pressure Sores
54
54
Insufficient Information
28
28
Injury
7
7
No Known Impact Or Consequence To Patient
7
7
Fall
6
6
Erythema
5
5
Ulcer
4
4
Unspecified Tissue Injury
4
4
Blister
3
3
No Patient Involvement
3
3
Tissue Breakdown
3
3
No Consequences Or Impact To Patient
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
2
2
Electric Shock
1
1
Head Injury
1
1
Hematoma
1
1
Inflammation
1
1
Damage to Ligament(s)
1
1
Pain
1
1
Scar Tissue
1
1
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
No Code Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Baxter Healthcare Corporation
II
Nov-02-2023
2
Baxter Healthcare Corporation
II
May-01-2023
3
Baxter Healthcare Corporation
II
Jul-20-2022
4
Baxter Healthcare Corporation
II
Mar-23-2022
5
Stryker Medical Division of Stryker Corporation
II
Sep-15-2018
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