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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 69 69

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 51 51
Material Split, Cut or Torn 44 44
Use of Device Problem 32 32
Inflation Problem 21 21
Pressure Problem 21 21
Activation Problem 14 14
Appropriate Term/Code Not Available 13 13
Mechanical Problem 11 11
Sparking 9 9
Insufficient Information 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Component or Accessory Incompatibility 7 7
Patient Device Interaction Problem 6 6
Material Too Soft/Flexible 6 6
Defective Alarm 6 6
No Audible Alarm 6 6
Decrease in Pressure 5 5
Break 4 4
Material Frayed 4 4
Scratched Material 4 4
Material Deformation 4 4
Gas/Air Leak 3 3
Deflation Problem 3 3
Electrical /Electronic Property Problem 3 3
Fire 2 2
Collapse 2 2
Use of Incorrect Control/Treatment Settings 2 2
Positioning Problem 2 2
Unintended Deflation 2 2
Sharp Edges 1 1
Complete Loss of Power 1 1
Power Problem 1 1
Temperature Problem 1 1
No Apparent Adverse Event 1 1
Device Alarm System 1 1
Connection Problem 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Grounding Malfunction 1 1
Material Puncture/Hole 1 1
Smoking 1 1
Misassembled 1 1
Patient-Device Incompatibility 1 1
Battery Problem 1 1
Improper or Incorrect Procedure or Method 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 155 155
Pressure Sores 55 55
Insufficient Information 29 29
Erythema 5 5
Fall 5 5
Ulcer 4 4
Unspecified Tissue Injury 4 4
Blister 3 3
Laceration(s) 3 3
Hemorrhage/Bleeding 2 2
Electric Shock 2 2
No Patient Involvement 2 2
Injury 2 2
No Known Impact Or Consequence To Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Depression 1 1
Low Oxygen Saturation 1 1
Tissue Breakdown 1 1
Cyanosis 1 1
Inflammation 1 1
Damage to Ligament(s) 1 1
Pain 1 1
Scar Tissue 1 1
No Consequences Or Impact To Patient 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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