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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

MDR Year MDR Reports MDR Events
2019 101 101
2020 58 58
2021 47 47
2022 75 75
2023 197 197
2024 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 150 150
Insufficient Information 73 73
Deflation Problem 53 53
Sparking 19 19
Use of Device Problem 18 18
Increase in Pressure 17 17
Appropriate Term/Code Not Available 17 17
Inflation Problem 16 16
Unintended Deflation 13 13
No Apparent Adverse Event 12 12
Patient-Device Incompatibility 11 11
Electrical /Electronic Property Problem 10 10
Electrical Shorting 10 10
Detachment of Device or Device Component 7 7
Unintended Electrical Shock 7 7
Fire 7 7
Infusion or Flow Problem 6 6
Decrease in Pressure 5 5
Device Slipped 5 5
Mechanical Problem 4 4
Patient Device Interaction Problem 4 4
Pressure Problem 4 4
Protective Measures Problem 3 3
Device-Device Incompatibility 3 3
Installation-Related Problem 3 3
No Pressure 3 3
Smoking 3 3
Product Quality Problem 3 3
Contamination /Decontamination Problem 2 2
Defective Component 2 2
Disconnection 2 2
Thermal Decomposition of Device 2 2
Use of Incorrect Control/Treatment Settings 2 2
Therapeutic or Diagnostic Output Failure 2 2
Sharp Edges 2 2
Device Fell 1 1
Complete Loss of Power 1 1
Inaccurate Information 1 1
Unclear Information 1 1
Air/Gas in Device 1 1
Device Dislodged or Dislocated 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Noise, Audible 1 1
Positioning Problem 1 1
Power Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Device Damaged by Another Device 1 1
Malposition of Device 1 1
Flare or Flash 1 1
Gas/Air Leak 1 1
Improper Flow or Infusion 1 1
Crack 1 1
Device Alarm System 1 1
Inability to Auto-Fill 1 1
Difficult or Delayed Positioning 1 1
Loose or Intermittent Connection 1 1
Unintended System Motion 1 1
Energy Output Problem 1 1
Overheating of Device 1 1
Failure to Power Up 1 1
Component Missing 1 1
Dent in Material 1 1
Defective Device 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Material Too Rigid or Stiff 1 1
Self-Activation or Keying 1 1
Short Fill 1 1
Inadequacy of Device Shape and/or Size 1 1
Inadequate or Insufficient Training 1 1
Decreased Pump Speed 1 1
Material Puncture/Hole 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Fall 202 202
Pressure Sores 84 84
No Clinical Signs, Symptoms or Conditions 65 65
Insufficient Information 19 19
No Consequences Or Impact To Patient 16 16
Ulcer 13 13
Pain 13 13
Bruise/Contusion 11 11
Bone Fracture(s) 10 10
Tissue Breakdown 10 10
Electric Shock 9 9
Skin Tears 8 8
No Known Impact Or Consequence To Patient 7 7
Head Injury 7 7
Laceration(s) 7 7
Death 6 6
Physical Entrapment 5 5
Localized Skin Lesion 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Injury 4 4
Hematoma 4 4
Pleural Effusion 4 4
Skin Erosion 4 4
Abrasion 4 4
Burn(s) 3 3
No Patient Involvement 3 3
Blister 3 3
Swelling/ Edema 2 2
Vertebral Fracture 2 2
Skin Infection 2 2
Joint Dislocation 2 2
Fungal Infection 2 2
Skull Fracture 2 2
Skin Discoloration 2 2
Swelling 1 1
Pneumonia 1 1
Contusion 1 1
Acoustic Shock 1 1
Headache 1 1
Fatigue 1 1
Neck Pain 1 1
Impaired Healing 1 1
Discomfort 1 1
Superficial (First Degree) Burn 1 1
No Code Available 1 1
Limb Fracture 1 1
Multiple Fractures 1 1
Skin Inflammation/ Irritation 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1

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