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 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 45 45

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 272 272
Activation Problem 43 43
Sparking 41 41
Material Frayed 22 22
Unintended Movement 17 17
Incorrect Measurement 17 59
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
Material Deformation 3 3
Unintended Electrical Shock 3 3
Device Alarm System 3 3
Use of Device Problem 2 2
Defective Component 2 2
Detachment of Device or Device Component 2 2
Defective Alarm 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
Patient Device Interaction Problem 1 1
Sharp Edges 1 1
Contamination /Decontamination Problem 1 1
Calibration Problem 1 1
Positioning 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
Intermittent Continuity 1 1
Melted 1 1
Unintended System Motion 1 1
Connection Problem 1 1
Self-Activation or Keying 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 424 473
Insufficient Information 33 33
Pressure Sores 11 11
Fall 9 9
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 3 3
Strangulation 2 2
Discomfort 2 2
Sepsis 1 1
Necrosis 1 1
Dizziness 1 1
Bone Fracture(s) 1 1
Abrasion 1 1
Localized Skin Lesion 1 1
No Known Impact Or Consequence To Patient 1 1
Burn(s) 1 1
Injury 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

-
-