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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
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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