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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
CAREFUSION
  SUBSTANTIALLY EQUIVALENT 3
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEOLIGHT, LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Melted 413
Overheating of Device 412
Device Issue 79
Device Operational Issue 47
Low Test Results 45
LED (Light Emitting Diode) 19
Output Problem 17
Energy Output Problem 12
Output below Specifications 11
Electrical /Electronic Property Problem 8
High Test Results 7
Use of Device Problem 5
Device Operates Differently Than Expected 4
Low Readings 4
Adverse Event Without Identified Device or Use Problem 3
Detachment of Device or device Component 2
Device Emits Odor 2
Improper Device Output 2
Break 2
Output above Specifications 2
Device Fell 1
Dent in Material 1
Electromagnetic Compatibility Problem 1
Unexpected Shutdown 1
Off-Label Use 1
Potentiometer 1
Current Source 1
Thermal Decomposition of Device 1
Patient-Device Incompatibility 1
Misassembly by Users 1
Electrical Shorting 1
Appropriate Term/Code Not Available 1
Circuit Failure 1
Device Inoperable 1
Excessive Cooling 1
Calibration Problem 1
Total Device Problems 1112

Recalls
Manufacturer Recall Class Date Posted
1 Lumitex Inc II Jan-31-2020
2 Natus Medical Incorporated II Apr-14-2017
3 Natus Medical Incorporated II Dec-15-2016
4 Natus Medical Incorporated II Dec-15-2016
5 Natus Medical Incorporated II Jun-15-2016
6 Natus Medical Incorporated II Oct-21-2015
7 Natus Medical Incorporated II Apr-10-2015
8 Ohmeda Medical II Mar-20-2017
9 Physician Engineered Products, Inc. II Aug-31-2015

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