TPLC - Total Product Life Cycle

• Device: warmer, infant radiant
• Product Code: FMT
• Regulation Number: 880.5130
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
DATEX OHMEDA INC.
	SUBSTANTIALLY EQUIVALENT	1
DEROYAL INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
DRAEGER MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
GE HEALTHCARE
	SUBSTANTIALLY EQUIVALENT	1
INTERNATIONAL BIOMEDICAL
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2018	79	79
2019	1437	1512
2020	1605	1605
2021	473	473
2022	153	153
2023	120	120
2024	27	27

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	3341	3415
Break	145	145
Crack	145	145
Electrical /Electronic Property Problem	43	43
Device Alarm System	34	34
Nonstandard Device	34	34
Output Problem	25	25
Incorrect, Inadequate or Imprecise Result or Readings	23	23
No Audible Alarm	20	20
Material Discolored	17	17
Fracture	17	17
Detachment of Device or Device Component	15	15
Mechanical Problem	14	14
Therapeutic or Diagnostic Output Failure	12	12
Microbial Contamination of Device	11	11
Contamination	8	8
Product Quality Problem	8	8
Device Displays Incorrect Message	7	7
Protective Measures Problem	7	8
Gas/Air Leak	6	6
Smoking	6	6
Overheating of Device	6	6
Melted	5	5
Defective Alarm	5	5
Device Issue	5	5
Temperature Problem	5	5
Appropriate Term/Code Not Available	5	5
No Apparent Adverse Event	4	4
Device Fell	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Device Damaged Prior to Use	4	4
Loss of or Failure to Bond	4	4
Thermal Decomposition of Device	4	4
Unable to Obtain Readings	4	4
Use of Device Problem	4	4
Improper or Incorrect Procedure or Method	3	3
Loose or Intermittent Connection	3	3
Device Emits Odor	3	3
Circuit Failure	3	3
Fire	3	3
Electrical Shorting	3	3
Low Readings	3	3
Insufficient Information	3	3
Device Handling Problem	3	3
Excessive Heating	3	3
Noise, Audible	2	2
Patient Device Interaction Problem	2	2
Connection Problem	2	2
Power Problem	2	2
Lack of Maintenance Documentation or Guidelines	2	2
Insufficient Heating	2	2
Kinked	1	1
Material Fragmentation	1	1
Gas Output Problem	1	1
Disconnection	1	1
Material Disintegration	1	1
Failure to Cycle	1	1
Loss of Power	1	1
Insufficient Flow or Under Infusion	1	1
No Audible Prompt/Feedback	1	1
Difficult to Remove	1	1
Material Separation	1	1
Failure to Read Input Signal	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Improper Flow or Infusion	1	1
Infusion or Flow Problem	1	1
Mechanics Altered	1	1
Moisture or Humidity Problem	1	1
Naturally Worn	1	1
No Pressure	1	1
Optical Discoloration	1	1
Unintended Movement	1	1
Misassembly by Users	1	1
Sparking	1	1
Contamination /Decontamination Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Free or Unrestricted Flow	1	1
Device Sensing Problem	1	1
Device Dislodged or Dislocated	1	1
Device Tipped Over	1	1
Overfill	1	1
Sticking	1	1
Fungus in Device Environment	1	1
Solder Joint Fracture	1	1
Unexpected Shutdown	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	2616	2691
No Clinical Signs, Symptoms or Conditions	812	812
Insufficient Information	321	321
No Known Impact Or Consequence To Patient	78	78
No Consequences Or Impact To Patient	27	27
Fall	10	10
Skull Fracture	6	6
Burn(s)	3	3
Low Oxygen Saturation	3	3
Alteration in Body Temperature	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Code Available	2	2
Inadequate Osseointegration	2	2
Thromboembolism	1	1
Superficial (First Degree) Burn	1	1
Swelling	1	1
Injury	1	1
Fungal Infection	1	1
Death	1	1
Edema	1	1
Bradycardia	1	1
Bruise/Contusion	1	1
Fever	1	1
Bone Fracture(s)	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1
Hypothermia	1	1
External Prosthetic Device Pain	1	1
Partial thickness (Second Degree) Burn	1	1
No Information	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Draeger Medical Systems, Inc.	II	Jun-22-2023
2	GE Healthcare, LLC	I	Dec-03-2019
3	GE Healthcare, LLC	I	Jul-11-2019
4	GE Healthcare, LLC	II	Nov-19-2018