TPLC - Total Product Life Cycle

• Device: unit, neonatal phototherapy
• Product Code: LBI
• Regulation Number: 880.5700
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
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

MDR Year	MDR Reports	MDR Events
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	17	17
Melted	15	15
Use of Device Problem	6	6
Device Operational Issue	6	6
Adverse Event Without Identified Device or Use Problem	4	4
Device Fell	4	4
Material Twisted/Bent	3	3
Low Test Results	3	3
Low Readings	3	3
Electrical /Electronic Property Problem	3	3
Break	2	2
Device Issue	2	2
Failure to Power Up	2	2
Smoking	2	2
Appropriate Term/Code Not Available	2	2
Dent in Material	2	2
Detachment of Device or Device Component	2	2
Loss of or Failure to Bond	1	1
Sparking	1	1
Patient-Device Incompatibility	1	1
Output Problem	1	1
Electromagnetic Compatibility Problem	1	1
Component Missing	1	1
High Test Results	1	1
Structural Problem	1	1
Thermal Decomposition of Device	1	1
Crack	1	1
Material Frayed	1	1
Output above Specifications	1	1
No Device Output	1	1
Loss of Power	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	38	38
No Clinical Signs, Symptoms or Conditions	9	9
No Consequences Or Impact To Patient	4	4
Skin Irritation	3	3
Burn, Thermal	2	2
No Patient Involvement	1	1
Inflammation	1	1
Rash	1	1
Skin Inflammation/ Irritation	1	1
Insufficient Information	1	1

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