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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bed, flotation therapy, powered
Product CodeIOQ
Regulation Number 890.5170
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 9 9
2021 56 56
2022 22 22
2023 111 111
2024 199 199

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 58 58
Material Split, Cut or Torn 54 54
Use of Device Problem 32 32
Pressure Problem 21 21
Inflation Problem 21 21
Activation Problem 14 14
Appropriate Term/Code Not Available 13 13
Mechanical Problem 11 11
Sparking 10 10
Insufficient Information 9 9
Component or Accessory Incompatibility 7 7
Material Too Soft/Flexible 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Patient Device Interaction Problem 6 6
No Audible Alarm 6 6
Defective Alarm 6 6
Decrease in Pressure 5 5
Material Frayed 4 4
Scratched Material 4 4
Material Deformation 4 4
Break 4 4
Deflation Problem 3 3
Electrical /Electronic Property Problem 3 3
Gas/Air Leak 3 3
Collapse 2 2
Unintended Deflation 2 2
Use of Incorrect Control/Treatment Settings 2 2
Smoking 2 2
Positioning Problem 2 2
Fire 2 2
Temperature Problem 1 1
Complete Loss of Power 1 1
Connection Problem 1 1
Grounding Malfunction 1 1
Naturally Worn 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Sharp Edges 1 1
Battery Problem 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1
Power Problem 1 1
Misassembled 1 1
Patient-Device Incompatibility 1 1
Material Puncture/Hole 1 1
Device Alarm System 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 271 271
Pressure Sores 55 55
Insufficient Information 41 41
Erythema 5 5
Fall 5 5
Unspecified Tissue Injury 4 4
Ulcer 4 4
Blister 3 3
Laceration(s) 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Electric Shock 2 2
No Known Impact Or Consequence To Patient 2 2
Injury 2 2
No Patient Involvement 2 2
Hemorrhage/Bleeding 2 2
Damage to Ligament(s) 1 1
Cyanosis 1 1
No Information 1 1
Inflammation 1 1
Cardiac Arrest 1 1
Depression 1 1
Scar Tissue 1 1
Pain 1 1
Shock 1 1
No Consequences Or Impact To Patient 1 1
Tissue Breakdown 1 1
Low Oxygen Saturation 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jun-14-2024
2 Baxter Healthcare Corporation II Mar-29-2024
3 Baxter Healthcare Corporation II Nov-02-2023
4 Baxter Healthcare Corporation II May-01-2023
5 Baxter Healthcare Corporation II Jul-20-2022
6 Baxter Healthcare Corporation II Mar-23-2022
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