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 mattress, air flotation, alternating pressure
Product CodeFNM
Regulation Number 880.5550
Device Class 2

MDR Year MDR Reports MDR Events
2018 115 115
2019 101 101
2020 58 58
2021 47 47
2022 75 75
2023 197 197
2024 57 57

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 213 213
Insufficient Information 82 82
Deflation Problem 62 62
Inflation Problem 26 26
Use of Device Problem 24 24
Sparking 23 23
Dent in Material 21 21
Increase in Pressure 19 19
Appropriate Term/Code Not Available 17 17
Unintended Deflation 13 13
No Apparent Adverse Event 12 12
Electrical /Electronic Property Problem 12 12
Patient-Device Incompatibility 11 11
Electrical Shorting 10 10
No Pressure 9 9
Infusion or Flow Problem 8 8
Fire 8 8
Decrease in Pressure 8 8
Failure to Power Up 7 7
Pressure Problem 7 7
Detachment of Device or Device Component 7 7
Unintended Electrical Shock 7 7
Computer Software Problem 6 6
Device Slipped 5 5
Installation-Related Problem 5 5
Unclear Information 5 5
Patient Device Interaction Problem 4 4
Malposition of Device 4 4
Inadequate or Insufficient Training 4 4
Product Quality Problem 4 4
Mechanical Problem 4 4
Difficult or Delayed Positioning 3 3
Smoking 3 3
Defective Component 3 3
Device-Device Incompatibility 3 3
Protective Measures Problem 3 3
Material Puncture/Hole 3 3
Therapeutic or Diagnostic Output Failure 2 2
Material Split, Cut or Torn 2 2
Sharp Edges 2 2
Complete Loss of Power 2 2
Gas/Air Leak 2 2
Device Operational Issue 2 2
Contamination /Decontamination Problem 2 2
Self-Activation or Keying 2 2
Material Separation 2 2
Use of Incorrect Control/Treatment Settings 2 2
Break 2 2
Thermal Decomposition of Device 2 2
Circuit Failure 2 2
Disconnection 2 2
Fail-Safe Design Failure 1 1
Melted 1 1
Moisture Damage 1 1
Unintended System Motion 1 1
Energy Output Problem 1 1
Overheating of Device 1 1
Device Alarm System 1 1
Inability to Auto-Fill 1 1
Bent 1 1
Crack 1 1
Material Discolored 1 1
Short Fill 1 1
Inadequacy of Device Shape and/or Size 1 1
Sticking 1 1
Device Inoperable 1 1
Material Too Rigid or Stiff 1 1
Decreased Pump Speed 1 1
Leak/Splash 1 1
Loose or Intermittent Connection 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Device Damaged by Another Device 1 1
Device Operates Differently Than Expected 1 1
Component Missing 1 1
Device Issue 1 1
Overfill 1 1
Defective Device 1 1
Human Factors Issue 1 1
Improper Flow or Infusion 1 1
Pumping Problem 1 1
Positioning Problem 1 1
Power Problem 1 1
Device Dislodged or Dislocated 1 1
Flare or Flash 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Misassembled During Installation 1 1
Inaccurate Information 1 1
Air/Gas in Device 1 1
Device Fell 1 1
Component Misassembled 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 275 275
Pressure Sores 109 109
No Clinical Signs, Symptoms or Conditions 74 74
No Consequences Or Impact To Patient 36 36
Tissue Breakdown 31 31
Pain 21 21
Insufficient Information 20 20
Ulcer 15 15
No Known Impact Or Consequence To Patient 13 13
Injury 12 12
Bone Fracture(s) 12 12
Bruise/Contusion 11 11
Electric Shock 11 11
Head Injury 10 10
Death 10 10
Laceration(s) 10 10
Skin Tears 8 8
Burn(s) 7 7
Hematoma 5 5
Physical Entrapment 5 5
Localized Skin Lesion 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Pleural Effusion 4 4
Skin Erosion 4 4
Contusion 4 4
Abrasion 4 4
Discomfort 3 3
No Patient Involvement 3 3
Blister 3 3
Vertebral Fracture 2 2
Swelling/ Edema 2 2
Skin Infection 2 2
Skin Discoloration 2 2
Fungal Infection 2 2
Hip Fracture 2 2
Joint Dislocation 2 2
Skull Fracture 2 2
Swelling 1 1
Pneumonia 1 1
Unspecified Infection 1 1
Acoustic Shock 1 1
Headache 1 1
Fatigue 1 1
Impaired Healing 1 1
Neck Pain 1 1
Superficial (First Degree) Burn 1 1
Skin Inflammation/ Irritation 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
No Information 1 1
No Code Available 1 1
Limb Fracture 1 1
Multiple Fractures 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Getinge (Suzhou) Co Ltd II Jun-04-2021
-
-