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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 8 8

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 Fell 4 4
Low Readings 4 4
Device Emits Odor 4 4
Smoking 3 3
Thermal Decomposition of Device 3 3
Appropriate Term/Code Not Available 3 3
Material Twisted/Bent 3 3
Break 2 2
Loss of Power 2 2
Failure to Power Up 2 2
Output above Specifications 2 2
Detachment of Device or Device Component 2 2
Dent in Material 2 2
Sparking 1 1
Patient-Device Incompatibility 1 1
Calibration Problem 1 1
Component Missing 1 1
Structural Problem 1 1
Electrical Shorting 1 1
Electromagnetic Compatibility Problem 1 1
Excessive Cooling 1 1
Improper Device Output 1 1
No Device Output 1 1
Nonstandard Device 1 1
Loss of or Failure to Bond 1 1
Material Frayed 1 1
Circuit Failure 1 1
Component Incompatible 1 1
Crack 1 1
Temperature Problem 1 1
Noise, Audible 1 1
Unexpected Shutdown 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 9 9
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
Skin Inflammation/ Irritation 1 1
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
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