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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 382 383

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 75 75
Unintended Movement 62 62
Use of Device Problem 32 32
Pressure Problem 21 21
Inflation Problem 21 21
Activation Problem 16 16
Appropriate Term/Code Not Available 14 14
Sparking 11 11
Mechanical Problem 11 11
Insufficient Information 11 11
Material Too Soft/Flexible 8 9
Component or Accessory Incompatibility 7 7
Adverse Event Without Identified Device or Use Problem 7 7
Material Frayed 6 6
Defective Alarm 6 6
No Audible Alarm 6 6
Patient Device Interaction Problem 6 6
Decrease in Pressure 5 5
Break 4 4
Electrical /Electronic Property Problem 4 4
Material Deformation 4 4
Scratched Material 4 4
Deflation Problem 3 3
Gas/Air Leak 3 3
Use of Incorrect Control/Treatment Settings 2 2
Positioning Problem 2 2
Smoking 2 2
Unintended Deflation 2 2
Collapse 2 2
Fire 2 2
Battery Problem 1 1
Degraded 1 1
Sharp Edges 1 1
Misassembled 1 1
Patient-Device Incompatibility 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Activation Failure 1 1
Material Puncture/Hole 1 1
Power Problem 1 1
Grounding Malfunction 1 1
Connection Problem 1 1
Naturally Worn 1 1
Device Alarm System 1 1
Complete Loss of Power 1 1
Improper or Incorrect Procedure or Method 1 1
Mechanical Jam 1 1
Temperature Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 429 430
Insufficient Information 61 61
Pressure Sores 56 56
Erythema 5 5
Fall 5 5
Unspecified Tissue Injury 5 5
Ulcer 4 4
Blister 3 3
Laceration(s) 3 3
Skin Infection 2 2
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
Cyanosis 1 1
Damage to Ligament(s) 1 1
No Information 1 1
Inflammation 1 1
Cardiac Arrest 1 1
Needle Stick/Puncture 1 1
Depression 1 1
Pain 1 1
Scar Tissue 1 1
Shock 1 1
No Consequences Or Impact To Patient 1 1
Low Oxygen Saturation 1 1
Tissue Breakdown 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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