TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ATOM MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
AVALON BIOMEDICAL (SHENZHEN) LIMITED
	SUBSTANTIALLY EQUIVALENT	1
BIO-MED USA
	SUBSTANTIALLY EQUIVALENT	1
BISTOS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DRAEGER MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
FANEM LDA
	SUBSTANTIALLY EQUIVALENT	1
INTERLECTRIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1
LITTLE SPARROWS TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
LUMITEX, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDIX I.C.S.A.
	SUBSTANTIALLY EQUIVALENT	2
NATUS MEDICAL INCORPORATED
	SUBSTANTIALLY EQUIVALENT	4
NEOLIGHT, LLC
	SUBSTANTIALLY EQUIVALENT	1
NEOMEDLIGHT
	SUBSTANTIALLY EQUIVALENT	1
PHYSICIAN ENGINEERED PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	2
WIPRO GE HEALTHCARE PRIVATE, LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Overheating of Device	416	416
Melted	415	415
Device Issue	79	79
Device Operational Issue	47	47
Low Test Results	45	45
Output Problem	18	18
Use of Device Problem	12	12
Energy Output Problem	12	12
Output below Specifications	11	11
Adverse Event Without Identified Device or Use Problem	8	8
Electrical /Electronic Property Problem	8	8
High Test Results	7	7
Device Operates Differently Than Expected	6	6
Device Emits Odor	6	6
Break	5	5
Thermal Decomposition of Device	5	5
Detachment of Device or Device Component	4	4
Low Readings	4	4
Device Fell	4	4
Appropriate Term/Code Not Available	3	3
Material Twisted/Bent	3	3
Smoking	3	3
Failure To Service	2	2
Device Inoperable	2	2
Improper or Incorrect Procedure or Method	2	2
Dent in Material	2	2
Output above Specifications	2	2
Loss of Power	2	2
Failure to Power Up	2	2
Improper Device Output	2	2
Maintenance Does Not Comply To Manufacturers Recommendations	2	2
Device Dislodged or Dislocated	2	2
Temperature Problem	2	2
Misassembly by Users	1	1
Protective Measures Problem	1	1
Noise, Audible	1	1
Unexpected Shutdown	1	1
Electrical Shorting	1	1
Electromagnetic Compatibility Problem	1	1
Excessive Cooling	1	1
Material Protrusion/Extrusion	1	1
Off-Label Use	1	1
No Device Output	1	1
Loss of or Failure to Bond	1	1
Circuit Failure	1	1
Component Falling	1	1
Component Incompatible	1	1
Crack	1	1
Material Frayed	1	1
Nonstandard Device	1	1
Device Tipped Over	1	1
Sparking	1	1
Patient-Device Incompatibility	1	1
Calibration Problem	1	1
Structural Problem	1	1
Component Missing	1	1
Unexpected Therapeutic Results	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	630	630
No Clinical Signs, Symptoms or Conditions	12	12
No Consequences Or Impact To Patient	9	9
Burn(s)	4	5
Skin Irritation	3	3
No Patient Involvement	3	3
Alteration In Body Temperature	2	2
Injury	2	2
Burn, Thermal	2	2
No Information	2	2
Erythema	2	2
Hemorrhage/Bleeding	1	1
Inflammation	1	1
Rash	1	1
Jaundice	1	1
Complaint, Ill-Defined	1	1
Skin Inflammation/ Irritation	1	1
Insufficient Information	1	1
Full thickness (Third Degree) Burn	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Draeger Medical Systems, Inc.	II	Jul-06-2012
2	Lumitex Inc	II	Jan-31-2020
3	Natus Medical Incorporated	II	Apr-14-2017
4	Natus Medical Incorporated	II	Dec-15-2016
5	Natus Medical Incorporated	II	Dec-15-2016
6	Natus Medical Incorporated	II	Jun-15-2016
7	Natus Medical Incorporated	II	Oct-21-2015
8	Natus Medical Incorporated	II	Apr-10-2015
9	Natus Medical Incorporated	II	Dec-22-2014
10	Natus Medical Incorporated	II	Nov-24-2009
11	Ohmeda Medical	II	Mar-20-2017
12	Physician Engineered Products, Inc.	II	Aug-31-2015