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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device bariatric bed
Regulation Description AC-powered adjustable hospital 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
2020 15 15
2021 30 39
2022 37 51
2023 176 185
2024 219 236
2025 86 95

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 295 295
Activation Problem 52 52
Sparking 42 42
Material Frayed 22 22
Unintended Movement 20 20
Incorrect Measurement 18 66
Appropriate Term/Code Not Available 14 14
Break 11 11
Positioning Failure 11 18
Electrical /Electronic Property Problem 10 10
Adverse Event Without Identified Device or Use Problem 9 9
No Audible Alarm 8 8
Mechanical Problem 7 7
Smoking 6 6
Inflation Problem 6 6
Device Fell 5 5
Fire 4 4
No Apparent Adverse Event 4 4
Insufficient Information 4 4
Temperature Problem 3 3
Loose or Intermittent Connection 3 3
Defective Alarm 3 3
Material Deformation 3 3
Use of Device Problem 3 3
Unintended Electrical Shock 3 3
Device Alarm System 3 3
Patient Device Interaction Problem 2 5
Defective Component 2 2
Detachment of Device or Device Component 2 2
Off-Label Use 2 2
Disconnection 2 2
Material Fragmentation 1 1
Material Discolored 1 1
Component Missing 1 1
Gas/Air Leak 1 1
Structural Problem 1 1
Contamination /Decontamination Problem 1 1
Sharp Edges 1 1
Positioning Problem 1 1
Calibration Problem 1 1
Device Handling Problem 1 1
Failure to Pump 1 1
Product Quality Problem 1 1
Electrical Shorting 1 1
Activation Failure 1 1
Activation, Positioning or Separation Problem 1 1
Intermittent Continuity 1 1
Melted 1 1
Unintended System Motion 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 464 522
Insufficient Information 33 33
Pressure Sores 11 11
Fall 10 10
No Patient Involvement 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Electric Shock 6 6
Laceration(s) 6 6
Unspecified Tissue Injury 5 5
Pain 4 7
Bone Fracture(s) 2 5
Discomfort 2 2
Strangulation 2 2
Sepsis 1 1
Necrosis 1 1
Dizziness 1 1
Abrasion 1 1
Localized Skin Lesion 1 1
No Known Impact Or Consequence To Patient 1 1
Cardiac Arrest 1 1
Injury 1 1
Burn(s) 1 1
Dyspnea 1 1
Balance Problems 1 1
Heart Failure/Congestive Heart Failure 1 1
Shock 1 1
Skin Tears 1 1
No Consequences Or Impact To Patient 1 1
Low Oxygen Saturation 1 1

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