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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bariatric bed
Definition A bed intended for obese patients weighing 500 pounds and above. Beds can expand from 38 to 60 inches in width.
Product CodeOSI
Regulation Number 880.5100
Device Class 2

MDR Year MDR Reports MDR Events
2019 22 22
2020 15 15
2021 30 39
2022 37 51
2023 176 185
2024 156 167

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 202 202
Activation Problem 38 38
Sparking 36 36
Material Frayed 21 21
Incorrect Measurement 14 50
Appropriate Term/Code Not Available 14 14
Unintended Movement 12 12
Adverse Event Without Identified Device or Use Problem 12 12
Break 11 11
Positioning Failure 9 16
Electrical /Electronic Property Problem 8 8
No Audible Alarm 8 8
Mechanical Problem 7 7
Device Alarm System 6 6
Inflation Problem 6 6
Smoking 5 5
Fire 5 5
No Apparent Adverse Event 4 4
Device Slipped 4 4
Insufficient Information 4 4
Device Fell 4 4
Material Deformation 3 3
Use of Device Problem 3 3
Temperature Problem 3 3
Loose or Intermittent Connection 3 3
Unintended System Motion 2 2
Detachment of Device or Device Component 2 2
Defective Alarm 2 2
Self-Activation or Keying 2 2
Defective Component 2 2
Unintended Electrical Shock 2 2
Disconnection 2 2
Contamination /Decontamination Problem 1 1
Patient Device Interaction Problem 1 1
Mechanical Jam 1 1
Thermal Decomposition of Device 1 1
Structural Problem 1 1
Sharp Edges 1 1
Burst Container or Vessel 1 1
Material Fragmentation 1 1
Positioning Problem 1 1
Component Missing 1 1
Gas/Air Leak 1 1
Material Discolored 1 1
Material Integrity Problem 1 1
Calibration Problem 1 1
Electrical Shorting 1 1
Leak/Splash 1 1
Failure to Pump 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 330 373
Insufficient Information 25 25
No Patient Involvement 18 18
Pressure Sores 13 13
Fall 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Electric Shock 5 5
Laceration(s) 5 5
Unspecified Tissue Injury 5 5
Pain 4 4
Strangulation 2 2
No Consequences Or Impact To Patient 2 2
Hip Fracture 1 1
Death 1 1
Sepsis 1 1
No Information 1 1
Necrosis 1 1
Bone Fracture(s) 1 1
Abrasion 1 1
Localized Skin Lesion 1 1
No Known Impact Or Consequence To Patient 1 1
Injury 1 1
Burn(s) 1 1
Discomfort 1 1
Dyspnea 1 1
Shock 1 1
Skin Tears 1 1
Erosion 1 1
Low Oxygen Saturation 1 1
Bruise/Contusion 1 1

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