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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


Premarket Reviews
ManufacturerDecision
HILL-ROM
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 35 35
2015 27 27
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 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 49 49
Use of Device Problem 35 35
Material Split, Cut or Torn 33 33
Insufficient Information 31 31
Inflation Problem 25 25
Adverse Event Without Identified Device or Use Problem 23 23
Pressure Problem 22 22
Device Slipped 22 22
Mechanical Problem 16 16
Appropriate Term/Code Not Available 13 13
Sparking 11 11
Activation Problem 10 10
Device Operates Differently Than Expected 8 8
Device Inoperable 8 8
Component or Accessory Incompatibility 7 7
Defective Alarm 7 7
No Audible Alarm 7 7
Break 7 7
Unintended Head Motion 6 6
Material Frayed 5 5
Device Alarm System 5 5
Smoking 5 5
Decrease in Pressure 5 5
Material Deformation 5 5
Scratched Material 4 4
Improper or Incorrect Procedure or Method 4 4
Electrical /Electronic Property Problem 4 4
Patient Device Interaction Problem 4 4
Use of Incorrect Control/Treatment Settings 3 3
Deflation Problem 3 3
Detachment Of Device Component 3 3
Device Displays Incorrect Message 3 3
Defective Device 3 3
Temperature Problem 3 3
Gas/Air Leak 3 3
Positioning Problem 2 2
Power Problem 2 2
Material Integrity Problem 2 2
Therapeutic or Diagnostic Output Failure 2 2
Defective Component 2 2
Connection Problem 2 2
Patient-Device Incompatibility 2 2
Collapse 2 2
Thermal Decomposition of Device 2 2
Fail-Safe Design Failure 2 2
Fire 2 2
Sticking 2 2
Inappropriate/Inadequate Shock/Stimulation 2 2
Unintended Deflation 2 2
Sharp Edges 1 1
Complete Loss of Power 1 1
No Apparent Adverse Event 1 1
Inadequacy of Device Shape and/or Size 1 1
Increase in Pressure 1 1
Material Puncture/Hole 1 1
Failure to Reset 1 1
Misassembled 1 1
Device Emits Odor 1 1
Loss of Power 1 1
Excess Flow or Over-Infusion 1 1
Difficult to Insert 1 1
Device Maintenance Issue 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Grounding Malfunction 1 1
Device Reprocessing Problem 1 1
Failure To Adhere Or Bond 1 1
Component Falling 1 1
Battery Problem 1 1
Malposition of Device 1 1
Device Operational Issue 1 1
Arcing 1 1
Device Tipped Over 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Material Protrusion/Extrusion 1 1
Mechanical Jam 1 1
Naturally Worn 1 1
Improper Device Output 1 1
Installation-Related Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 124 124
Pressure Sores 70 70
No Known Impact Or Consequence To Patient 52 52
Insufficient Information 28 28
Fall 19 19
No Consequences Or Impact To Patient 16 16
Injury 15 15
Tissue Breakdown 14 14
Erythema 6 6
No Information 6 6
Electric Shock 5 5
No Patient Involvement 4 4
Ulcer 4 4
No Code Available 4 4
Unspecified Tissue Injury 4 4
Blister 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Death 2 2
Swelling 2 2
Bone Fracture(s) 2 2
Head Injury 2 2
Wound Dehiscence 2 2
Pain 2 2
Respiratory Distress 1 1
Scar Tissue 1 1
Shock 1 1
Skin Erosion 1 1
Spinal Column Injury 1 1
Bacterial Infection 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Contusion 1 1
Cyanosis 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Inflammation 1 1
Laceration(s) 1 1
Damage to Ligament(s) 1 1
Tissue Damage 1 1
Therapeutic Response, Decreased 1 1
Physical Entrapment 1 1
Discomfort 1 1
Device Embedded In Tissue or Plaque 1 1
Hip Fracture 1 1
Low Oxygen Saturation 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
6 Hill-Rom Manufacturing, Inc. II Feb-15-2011
7 Hill-Rom Manufacturing, Inc. II Aug-03-2009
8 Hill-Rom, Inc. II Jul-23-2013
9 Hill-Rom, Inc. II Mar-14-2013
10 KCI USA, Inc. II Nov-20-2012
11 KCI USA, Inc. II Jan-25-2010
12 Stryker Medical Division of Stryker Corporation II Sep-15-2018
13 Stryker Medical Division of Stryker Corporation II Aug-09-2013
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