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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 58 58

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 51 51
Material Split, Cut or Torn 41 41
Use of Device Problem 29 29
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
Component or Accessory Incompatibility 7 7
Patient Device Interaction Problem 6 6
Adverse Event Without Identified Device or Use Problem 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
Material Too Soft/Flexible 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 147 147
Pressure Sores 54 54
Insufficient Information 28 28
Erythema 5 5
Fall 5 5
Ulcer 4 4
Unspecified Tissue Injury 4 4
Blister 3 3
No Known Impact Or Consequence To Patient 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Electric Shock 2 2
No Patient Involvement 2 2
Injury 2 2
Hemorrhage/Bleeding 2 2
Laceration(s) 2 2
Damage to Ligament(s) 1 1
Pain 1 1
Scar Tissue 1 1
No Consequences Or Impact To Patient 1 1
Inflammation 1 1
Depression 1 1
Low Oxygen Saturation 1 1
Tissue Breakdown 1 1
Cyanosis 1 1
Device Embedded In Tissue or Plaque 1 1
No Information 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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