• 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 unit, neonatal phototherapy
Product CodeLBI
Regulation Number 880.5700
Device Class 2


Premarket Reviews
ManufacturerDecision
AVALON BIOMEDICAL (SHENZHEN) LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BISTOS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LITTLE SPARROWS TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NATUS MEDICAL INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NEOLIGHT, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEOMEDLIGHT
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 577 577
2018 37 37
2019 6 6
2020 6 6
2021 2 2
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Overheating of Device 405 405
Melted 404 404
Device Issue 79 79
Device Operational Issue 46 46
Low Test Results 45 45
Output Problem 18 18
Energy Output Problem 12 12
Output below Specifications 11 11
Use of Device Problem 10 10
Electrical /Electronic Property Problem 8 8
High Test Results 7 7
Device Operates Differently Than Expected 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Device Emits Odor 4 4
Device Fell 4 4
Low Readings 4 4
Material Twisted/Bent 3 3
Thermal Decomposition of Device 3 3
Smoking 3 3
Appropriate Term/Code Not Available 2 2
Detachment of Device or Device Component 2 2
Output above Specifications 2 2
Loss of Power 2 2
Failure to Power Up 2 2
Sparking 1 1
Patient-Device Incompatibility 1 1
Component Incompatible 1 1
Excessive Cooling 1 1
Unexpected Shutdown 1 1
Dent in Material 1 1
Electrical Shorting 1 1
Improper Device Output 1 1
Circuit Failure 1 1
Electromagnetic Compatibility Problem 1 1
Noise, Audible 1 1
Temperature Problem 1 1
Component Missing 1 1
Structural Problem 1 1
Calibration Problem 1 1
Nonstandard Device 1 1
No Device Output 1 1
Loss of or Failure to Bond 1 1
Break 1 1
Crack 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 611 611
No Clinical Signs, Symptoms or Conditions 7 7
No Consequences Or Impact To Patient 5 5
No Patient Involvement 3 3
Skin Irritation 3 3
Burn, Thermal 2 2
No Information 2 2
Insufficient Information 1 1
Alteration In Body Temperature 1 1
Jaundice 1 1
Inflammation 1 1
Rash 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Lumitex Inc II Jan-31-2020
2 Natus Medical Incorporated II Apr-14-2017
3 Ohmeda Medical II Mar-20-2017
-
-