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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
LITTLE SPARROWS TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 6 6
2020 6 6
2021 2 2
2022 8 8
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Use of Device Problem 3 3
Detachment of Device or Device Component 3 3
Material Twisted/Bent 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Device Fell 3 3
Appropriate Term/Code Not Available 2 2
Device Dislodged or Dislocated 2 2
Dent in Material 2 2
Failure to Power Up 2 2
Break 2 2
Overheating of Device 2 2
Loss of Power 1 1
Crack 1 1
Material Frayed 1 1
Smoking 1 1
Component Missing 1 1
Structural Problem 1 1
Device Tipped Over 1 1
Sparking 1 1
Patient-Device Incompatibility 1 1
Output Problem 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12 12
No Known Impact Or Consequence To Patient 5 5
Skin Irritation 3 3
No Consequences Or Impact To Patient 2 2
Burn, Thermal 1 1
Skin Inflammation/ Irritation 1 1
Insufficient Information 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Lumitex Inc II Jan-31-2020
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