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	34	34

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	3333	3407
Break	137	137
Crack	115	115
Device Alarm System	36	36
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
Detachment of Device or Device Component	16	16
Material Discolored	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
Gas/Air Leak	8	8
Protective Measures Problem	6	7
Smoking	6	6
Defective Alarm	5	5
Appropriate Term/Code Not Available	5	5
Temperature Problem	4	4
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
Device Damaged Prior to Use	4	4
Excessive Heating	3	3
Device Fell	3	3
Loose or Intermittent Connection	3	3
Circuit Failure	3	3
Fire	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
Insufficient Information	2	2
Device Handling Problem	2	2
Lack of Maintenance Documentation or Guidelines	2	2
Power Problem	2	2
Insufficient Heating	2	2
Use of Device Problem	2	2
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
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
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	819	819
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