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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
Regulation Description Neonatal phototherapy unit.
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

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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4 4
Device Fell 3 3
Use of Device Problem 3 3
Material Twisted/Bent 3 3
Device Dislodged or Dislocated 3 3
Dent in Material 2 2
Detachment of Device or Device Component 2 2
Material Frayed 1 1
Sparking 1 1
Break 1 1
Device Tipped Over 1 1
Output Problem 1 1
Patient-Device Incompatibility 1 1
Smoking 1 1
Component Missing 1 1
Structural Problem 1 1
Appropriate Term/Code Not Available 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 14 14
Skin Irritation 3 3
Skin Inflammation/ Irritation 1 1
No Known Impact Or Consequence To Patient 1 1
Insufficient Information 1 1
Partial thickness (Second Degree) Burn 1 1
No Consequences Or Impact To Patient 1 1

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