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TPLC
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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
1. K173516
NuBorne Infant Warmer
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
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