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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
2020 58 58
2021 47 47
2022 75 75
2023 197 197
2024 254 254

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 86 86
Insufficient Information 76 76
Deflation Problem 59 59
Increase in Pressure 35 35
Sparking 32 32
Dent in Material 23 23
Appropriate Term/Code Not Available 19 19
Use of Device Problem 19 19
Inflation Problem 15 15
Unintended Deflation 13 13
No Apparent Adverse Event 11 11
Electrical Shorting 11 11
Patient-Device Incompatibility 11 11
Electrical /Electronic Property Problem 10 10
Unintended Electrical Shock 9 9
Melted 8 8
Infusion or Flow Problem 8 8
Smoking 7 7
Pressure Problem 6 6
Fire 6 6
Detachment of Device or Device Component 6 6
Difficult or Delayed Positioning 4 4
Patient Device Interaction Problem 4 4
Device Slipped 4 4
Malposition of Device 4 4
Mechanical Problem 4 4
Defective Component 3 3
Gas/Air Leak 3 3
Protective Measures Problem 3 3
Product Quality Problem 3 3
Therapeutic or Diagnostic Output Failure 2 2
Circuit Failure 2 2
Contamination /Decontamination Problem 2 2
Self-Activation or Keying 2 2
No Pressure 2 2
Material Too Rigid or Stiff 2 2
Complete Loss of Power 2 2
Disconnection 2 2
Thermal Decomposition of Device 2 2
Decrease in Pressure 2 2
Sharp Edges 2 2
Device-Device Incompatibility 2 2
Inadequacy of Device Shape and/or Size 2 2
Material Split, Cut or Torn 2 2
Installation-Related Problem 2 2
Noise, Audible 1 1
Loose or Intermittent Connection 1 1
Inaccurate Information 1 1
Connection Problem 1 1
Inadequate or Insufficient Training 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 226 226
Fall 151 151
Pressure Sores 99 99
Insufficient Information 34 34
Tissue Breakdown 32 32
Ulcer 16 16
Skin Tears 15 15
Pain 14 14
No Consequences Or Impact To Patient 11 11
Electric Shock 11 11
Bruise/Contusion 8 8
Bone Fracture(s) 7 7
Head Injury 7 7
Laceration(s) 6 6
Physical Entrapment 5 5
Localized Skin Lesion 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Joint Dislocation 4 4
Pleural Effusion 4 4
Abrasion 4 4
Skin Erosion 4 4
Burn(s) 3 3
Blister 3 3
Hematoma 3 3
Skin Discoloration 2 2
Injury 2 2
No Patient Involvement 2 2
Skull Fracture 2 2
Fungal Infection 2 2
Swelling/ Edema 2 2
Skin Infection 2 2
Vertebral Fracture 2 2
No Known Impact Or Consequence To Patient 1 1
Contusion 1 1
Neck Pain 1 1
Multiple Fractures 1 1
Swelling 1 1
Discomfort 1 1
Skin Inflammation/ Irritation 1 1
Pneumonia 1 1
Fatigue 1 1
Limb Fracture 1 1
Contact Dermatitis 1 1
Unspecified Tissue Injury 1 1
Acoustic Shock 1 1
Hip Fracture 1 1
Headache 1 1
Superficial (First Degree) Burn 1 1
Impaired Healing 1 1
Unspecified Infection 1 1

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