• 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 bed, manual
Product CodeFNJ
Regulation Number 880.5120
Device Class 1

MDR Year MDR Reports MDR Events
2018 3 3
2019 7 7
2020 4 4
2021 8 8
2022 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
No Audible Alarm 11 11
Unintended Movement 10 10
Adverse Event Without Identified Device or Use Problem 5 5
Defective Alarm 2 2
Device Slipped 2 2
Component Missing 2 2
Defective Component 2 2
Patient Device Interaction Problem 2 2
Installation-Related Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Physical Resistance/Sticking 1 1
Activation, Positioning or Separation Problem 1 1
No Apparent Adverse Event 1 1
Break 1 1
Collapse 1 1
Entrapment of Device 1 1
Loose or Intermittent Connection 1 1
Device Damaged Prior to Use 1 1
Sharp Edges 1 1
Device Alarm System 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25 25
Laceration(s) 5 5
Fall 4 4
Physical Entrapment 4 4
Injury 2 2
No Patient Involvement 1 1
Limb Fracture 1 1
Pain 1 1
Eye Injury 1 1
Loss of consciousness 1 1
Strangulation 1 1
Death 1 1
Bone Fracture(s) 1 1
No Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Oakworks Inc II Jun-06-2022
-
-