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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 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 46 46
Material Split, Cut or Torn 33 33
Use of Device Problem 28 28
Inflation Problem 21 21
Pressure Problem 21 21
Appropriate Term/Code Not Available 13 13
Mechanical Problem 11 11
Activation Problem 10 10
Insufficient Information 9 9
Sparking 9 9
Component or Accessory Incompatibility 7 7
Defective Alarm 6 6
No Audible Alarm 5 5
Decrease in Pressure 5 5
Break 4 4
Material Frayed 4 4
Material Deformation 4 4
Patient Device Interaction Problem 4 4
Scratched Material 4 4
Adverse Event Without Identified Device or Use Problem 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 124 124
Pressure Sores 52 52
Insufficient Information 28 28
Erythema 5 5
Fall 5 5
Ulcer 4 4
Unspecified Tissue Injury 4 4
Blister 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Injury 2 2
Electric Shock 2 2
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 2 2
Device Embedded In Tissue or Plaque 1 1
No Information 1 1
Tissue Breakdown 1 1
Low Oxygen Saturation 1 1
Cyanosis 1 1
Inflammation 1 1
Laceration(s) 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 Mar-29-2024
2 Baxter Healthcare Corporation II Nov-02-2023
3 Baxter Healthcare Corporation II May-01-2023
4 Baxter Healthcare Corporation II Jul-20-2022
5 Baxter Healthcare Corporation II Mar-23-2022
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