• 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 lift, patient, ac-powered
Product CodeFNG
Regulation Number 880.5500
Device Class 2

MDR Year MDR Reports MDR Events
2019 4 4
2020 5 5
2021 4 4
2022 5 5
2023 16 16
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Device Tipped Over 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Appropriate Term/Code Not Available 3 3
Unintended Movement 2 2
Sharp Edges 2 2
Device Fell 1 1
Insufficient Information 1 1
Physical Resistance/Sticking 1 1
Detachment of Device or Device Component 1 1
Failure to Auto Stop 1 1
Material Deformation 1 1
Collapse 1 1
Corroded 1 1
Crack 1 1
Material Erosion 1 1
Unintended System Motion 1 1
Overheating of Device 1 1
Failure to Read Input Signal 1 1
Device Slipped 1 1
Inaccurate Synchronization 1 1
Unstable 1 1
Fumes or Vapors 1 1
Separation Failure 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13 13
Fall 6 6
Laceration(s) 6 6
Bone Fracture(s) 4 4
Hematoma 1 1
Hemorrhage/Bleeding 1 1
Bruise/Contusion 1 1
Death 1 1
No Consequences Or Impact To Patient 1 1
Injury 1 1
Hip Fracture 1 1
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Insufficient Information 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Raye's Inc. II Apr-18-2024
2 Tollos II Nov-17-2022
-
-