Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device bed, flotation therapy, powered
Product CodeIOQ
Regulation Number 890.5170
Device Class 2

MDR Year MDR Reports MDR Events
2016 42 42
2017 22 22
2018 20 20
2019 4 4
2020 9 9
2021 56 56
2022 22 22
2023 111 111
2024 199 199

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 61 61
Material Split, Cut or Torn 54 54
Use of Device Problem 37 37
Insufficient Information 25 25
Inflation Problem 23 23
Pressure Problem 22 22
Adverse Event Without Identified Device or Use Problem 21 21
Activation Problem 14 14
Mechanical Problem 13 13
Appropriate Term/Code Not Available 13 13
Sparking 10 10
Device Slipped 8 8
No Audible Alarm 8 8
Component or Accessory Incompatibility 7 7
Material Too Soft/Flexible 7 7
Defective Alarm 7 7
Device Operates Differently Than Expected 6 6
Patient Device Interaction Problem 6 6
Break 5 5
Decrease in Pressure 5 5
Electrical /Electronic Property Problem 4 4
Unintended Head Motion 4 4
Material Deformation 4 4
Scratched Material 4 4
Material Frayed 4 4
Deflation Problem 3 3
Temperature Problem 3 3
Device Displays Incorrect Message 3 3
Defective Device 3 3
Gas/Air Leak 3 3
Smoking 3 3
Device Alarm System 3 3
Therapeutic or Diagnostic Output Failure 2 2
Positioning Problem 2 2
Detachment Of Device Component 2 2
Improper or Incorrect Procedure or Method 2 2
Unintended Deflation 2 2
Use of Incorrect Control/Treatment Settings 2 2
Patient-Device Incompatibility 2 2
Fire 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Connection Problem 2 2
Collapse 2 2
Power Problem 2 2
Mechanical Jam 1 1
Loss of Power 1 1
Device Inoperable 1 1
Complete Loss of Power 1 1
Naturally Worn 1 1
Malposition of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 271 271
Pressure Sores 70 70
Insufficient Information 41 41
No Known Impact Or Consequence To Patient 25 25
Fall 11 11
Injury 11 11
Tissue Breakdown 9 9
Erythema 6 6
Ulcer 4 4
Unspecified Tissue Injury 4 4
Electric Shock 4 4
No Code Available 4 4
No Information 4 4
No Patient Involvement 4 4
No Consequences Or Impact To Patient 3 3
Hemorrhage/Bleeding 3 3
Laceration(s) 3 3
Blister 3 3
Pain 2 2
Swelling 2 2
Bone Fracture(s) 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Spinal Column Injury 1 1
Cardiac Arrest 1 1
Discomfort 1 1
Depression 1 1
Inflammation 1 1
Hematoma 1 1
Head Injury 1 1
Respiratory Distress 1 1
Scar Tissue 1 1
Physical Entrapment 1 1
Shock 1 1
Hip Fracture 1 1
Tissue Damage 1 1
Death 1 1
Bacterial Infection 1 1
Wound Dehiscence 1 1
Damage to Ligament(s) 1 1
Low Oxygen Saturation 1 1
Cyanosis 1 1
Bruise/Contusion 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
7 Stryker Medical Division of Stryker Corporation II Sep-15-2018
-
-