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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device warmer, infant radiant
Product CodeFMT
Regulation Number 880.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
ATOM MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
DATEX OHMEDA INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
OHMEDA MEDICAL, A DIVISION OF DATEX-OHMEDA, INC.,
  SUBSTANTIALLY EQUIVALENT 2
WIPRO GE HEALTHCARE PRIVATE, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 79 79
2015 56 56
2016 56 56
2017 46 46
2018 79 79
2019 1437 1512
2020 1605 1605
2021 473 473
2022 153 153
2023 120 120
2024 47 47

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 3342 3416
Crack 219 219
Break 169 169
Device Alarm System 54 54
Electrical /Electronic Property Problem 46 46
Material Discolored 39 39
No Audible Alarm 38 38
Nonstandard Device 34 34
Device Displays Incorrect Message 29 29
Output Problem 29 29
Device Issue 27 27
Incorrect, Inadequate or Imprecise Result or Readings 26 26
Mechanical Problem 18 18
Fracture 17 17
Detachment of Device or Device Component 16 16
Device Operates Differently Than Expected 15 15
Therapeutic or Diagnostic Output Failure 12 12
Gas/Air Leak 11 11
Microbial Contamination of Device 11 11
Defective Alarm 11 11
Thermal Decomposition of Device 9 9
Overheating of Device 9 9
Product Quality Problem 9 9
Temperature Problem 9 9
Adverse Event Without Identified Device or Use Problem 9 9
Protective Measures Problem 8 9
Contamination 8 8
Smoking 7 7
Device Damaged Prior to Use 6 6
Unable to Obtain Readings 6 6
Appropriate Term/Code Not Available 6 6
Device Handling Problem 5 5
Use of Device Problem 5 5
Failure To Adhere Or Bond 5 5
Melted 5 5
Loose or Intermittent Connection 4 4
Loss of or Failure to Bond 4 4
Insufficient Flow or Under Infusion 4 4
Low Readings 4 4
No Apparent Adverse Event 4 4
Mechanics Altered 4 4
Device Fell 4 4
Excessive Heating 3 3
Device Inoperable 3 3
Electrical Shorting 3 3
Insufficient Information 3 3
Noise, Audible 3 3
Sparking 3 3
Improper or Incorrect Procedure or Method 3 3
Sticking 3 3
Loss of Power 3 3
Component Falling 3 3
Circuit Failure 3 3
Device Maintenance Issue 3 3
Device Emits Odor 3 3
Insufficient Heating 3 3
Display or Visual Feedback Problem 3 3
Fire 3 3
Poor Quality Image 2 2
Detachment Of Device Component 2 2
Unexpected Therapeutic Results 2 2
Defective Component 2 2
Patient Device Interaction Problem 2 2
Physical Property Issue 2 2
Power Problem 2 2
Improper Device Output 2 2
Connection Problem 2 2
Lack of Maintenance Documentation or Guidelines 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Medical Gas Supply Problem 1 1
Moisture or Humidity Problem 1 1
Naturally Worn 1 1
Improper Flow or Infusion 1 1
Compatibility Problem 1 1
Infusion or Flow Problem 1 1
Installation-Related Problem 1 1
Failure to Shut Off 1 1
Device Contamination with Chemical or Other Material 1 1
Free or Unrestricted Flow 1 1
No Pressure 1 1
Optical Discoloration 1 1
Mechanical Jam 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Unexpected Shutdown 1 1
No Audible Prompt/Feedback 1 1
Failure to Power Up 1 1
Difficult to Remove 1 1
Material Separation 1 1
Failure to Read Input Signal 1 1
Inadequacy of Device Shape and/or Size 1 1
Patient-Device Incompatibility 1 1
Contamination /Decontamination Problem 1 1
Device Operational Issue 1 1
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Device Tipped Over 1 1
Overfill 1 1
High Readings 1 1
Fungus in Device Environment 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2689 2764
No Clinical Signs, Symptoms or Conditions 831 831
Insufficient Information 321 321
No Known Impact Or Consequence To Patient 182 182
No Consequences Or Impact To Patient 65 65
Fall 12 12
No Information 8 8
Skull Fracture 7 7
Burn(s) 6 6
No Code Available 5 5
Hypothermia 4 4
Alteration in Body Temperature 3 3
Low Oxygen Saturation 3 3
Superficial (First Degree) Burn 2 2
Injury 2 2
Inadequate Osseointegration 2 2
Not Applicable 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
External Prosthetic Device Pain 1 1
Partial thickness (Second Degree) Burn 1 1
Thromboembolism 1 1
Alteration In Body Temperature 1 1
Fungal Infection 1 1
Hypoxia 1 1
Skin Discoloration 1 1
Complaint, Ill-Defined 1 1
Swelling 1 1
Tachycardia 1 1
Tissue Damage 1 1
Death 1 1
Edema 1 1
Abrasion 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Fever 1 1
Bone Fracture(s) 1 1
Hematoma 1 1
Hemorrhage/Bleeding 1 1

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Nov-30-2015
2 Draeger Medical Systems, Inc. II Jun-22-2023
3 Draeger Medical Systems, Inc. II Aug-26-2009
4 Draeger Medical Systems, Inc. I Aug-25-2009
5 Draeger Medical, Inc. II Jul-28-2016
6 Fisher & Paykel Healthcare, Ltd. II Nov-13-2014
7 GE Healthcare II May-06-2014
8 GE Healthcare II Feb-03-2014
9 GE Healthcare, LLC I Dec-03-2019
10 GE Healthcare, LLC I Jul-11-2019
11 GE Healthcare, LLC II Nov-19-2018
12 GE Healthcare, LLC II May-19-2017
13 GE Healthcare, LLC II Jan-11-2017
14 Ohmeda Medical II Mar-20-2017
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