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

MDR Year	MDR Reports	MDR Events
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	3333	3407
Break	135	135
Crack	115	115
Device Alarm System	34	34
Nonstandard Device	34	34
Electrical /Electronic Property Problem	33	33
Output Problem	22	22
Incorrect, Inadequate or Imprecise Result or Readings	20	20
Fracture	17	17
No Audible Alarm	17	17
Material Discolored	15	15
Detachment of Device or Device Component	15	15
Mechanical Problem	14	14
Therapeutic or Diagnostic Output Failure	12	12
Microbial Contamination of Device	10	10
Product Quality Problem	8	8
Contamination	8	8
Smoking	6	6
Protective Measures Problem	6	7
Gas/Air Leak	6	6
Appropriate Term/Code Not Available	5	5
Defective Alarm	5	5
Loss of or Failure to Bond	4	4
Thermal Decomposition of Device	4	4
Unable to Obtain Readings	4	4
Overheating of Device	4	4
Melted	4	4
Temperature Problem	4	4
Device Damaged Prior to Use	4	4
Excessive Heating	3	3
Device Fell	3	3
Adverse Event Without Identified Device or Use Problem	3	3
No Apparent Adverse Event	3	3
Electrical Shorting	3	3
Improper or Incorrect Procedure or Method	3	3
Device Displays Incorrect Message	3	3
Loose or Intermittent Connection	3	3
Circuit Failure	3	3
Fire	3	3
Insufficient Heating	2	2
Use of Device Problem	2	2
Insufficient Information	2	2
Device Handling Problem	2	2
Lack of Maintenance Documentation or Guidelines	2	2
Power Problem	2	2
Manufacturing, Packaging or Shipping Problem	1	1
No Pressure	1	1
Optical Discoloration	1	1
Noise, Audible	1	1
Patient Device Interaction Problem	1	1
Unintended Movement	1	1
Misassembly by Users	1	1
Sparking	1	1
Contamination /Decontamination Problem	1	1
Connection Problem	1	1
Insufficient Flow or Under Infusion	1	1
No Audible Prompt/Feedback	1	1
Device Sensing Problem	1	1
Device Dislodged or Dislocated	1	1
Free or Unrestricted Flow	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
Material Separation	1	1
Fungus in Device Environment	1	1
Solder Joint Fracture	1	1
Overfill	1	1
Device Tipped Over	1	1
Device Emits Odor	1	1
Material Fragmentation	1	1
Gas Output Problem	1	1
Disconnection	1	1
Material Disintegration	1	1
Failure to Cycle	1	1
Unexpected Shutdown	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Patient Involvement	2583	2658
No Clinical Signs, Symptoms or Conditions	812	812
Insufficient Information	321	321
No Known Impact Or Consequence To Patient	51	51
No Consequences Or Impact To Patient	15	15
Fall	7	7
Skull Fracture	5	5
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
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
Partial thickness (Second Degree) Burn	1	1
External Prosthetic Device Pain	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