• 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 analyzer, body composition
Regulation Description Impedance plethysmograph.
Product CodeMNW
Regulation Number 870.2770
Device Class 2

MDR Year MDR Reports MDR Events
2016 15 15
2017 6 6
2018 16 16
2019 11 11
2020 12 12
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 33 33
Material Fragmentation 6 6
Burst Container or Vessel 4 4
Explosion 3 3
Scratched Material 2 2
Self-Activation or Keying 2 2
Material Disintegration 2 2
Mechanical Problem 2 2
Patient-Device Incompatibility 2 2
Insufficient Information 2 2
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Expulsion 1 1
Physical Property Issue 1 1
Temperature Problem 1 1
Melted 1 1
Overheating of Device 1 1
Device Slipped 1 1
Device Tipped Over 1 1
False Positive Result 1 1
Fire 1 1
Crack 1 1
Improper or Incorrect Procedure or Method 1 1
Device Damaged Prior to Use 1 1
Extrusion 1 1
Mechanics Altered 1 1
Premature Discharge of Battery 1 1
Component Falling 1 1
Electrical /Electronic Property Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 19 19
No Consequences Or Impact To Patient 13 13
Injury 8 8
No Clinical Signs, Symptoms or Conditions 7 7
Laceration(s) 4 4
Pain 2 2
No Information 2 2
Tissue Damage 1 1
Dizziness 1 1
Discomfort 1 1
Burn, Thermal 1 1
No Patient Involvement 1 1
Test Result 1 1
Device Embedded In Tissue or Plaque 1 1
Partial thickness (Second Degree) Burn 1 1
Insufficient Information 1 1
Sleep Dysfunction 1 1
Superficial (First Degree) Burn 1 1
Burn(s) 1 1
Inflammation 1 1
Misdiagnosis 1 1

-
-