• 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 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Break 35 35
Material Fragmentation 6 6
Burst Container or Vessel 4 4
Explosion 3 3
Patient-Device Incompatibility 2 2
Scratched Material 2 2
Insufficient Information 2 2
Material Disintegration 2 2
Mechanical Problem 2 2
Self-Activation or Keying 2 2
Device Damaged Prior to Use 2 2
Device Tipped Over 1 1
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Melted 1 1
Device Emits Odor 1 1
Overheating of Device 1 1
Electrical /Electronic Property Problem 1 1
False Positive Result 1 1
Fire 1 1
Component Falling 1 1
Crack 1 1
Thermal Decomposition of Device 1 1
Premature Discharge of Battery 1 1
Temperature Problem 1 1
Detachment of Device or Device Component 1 1
Device Operates Differently Than Expected 1 1
Expulsion 1 1
Extrusion 1 1
Mechanics Altered 1 1
Physical Property Issue 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
No Clinical Signs, Symptoms or Conditions 10 10
Injury 8 8
Laceration(s) 4 4
Pain 2 2
No Information 2 2
Insufficient Information 2 2
Tissue Damage 1 1
Misdiagnosis 1 1
Dizziness 1 1
Discomfort 1 1
Burn(s) 1 1
Inflammation 1 1
Sleep Dysfunction 1 1
Burn, Thermal 1 1
No Patient Involvement 1 1
Superficial (First Degree) Burn 1 1
Partial thickness (Second Degree) Burn 1 1
Test Result 1 1
Device Embedded In Tissue or Plaque 1 1

-
-