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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
DATEX OHMEDA INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 46 46
2018 79 79
2019 1437 1512
2020 1605 1605
2021 473 473
2022 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 3341 3415
Crack 104 104
Break 72 72
Electrical /Electronic Property Problem 45 45
Nonstandard Device 34 34
No Audible Alarm 26 26
Output Problem 26 26
Device Alarm System 24 24
Incorrect, Inadequate or Imprecise Resultor Readings 23 23
Material Discolored 18 18
Device Issue 16 16
Fracture 14 14
Mechanical Problem 12 12
Detachment of Device or Device Component 11 11
Therapeutic or Diagnostic Output Failure 10 10
Device Displays Incorrect Message 8 8
Temperature Problem 8 8
Protective Measures Problem 6 7
Unable to Obtain Readings 6 6
Use of Device Problem 5 5
Appropriate Term/Code Not Available 5 5
Low Readings 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Defective Alarm 4 4
Thermal Decomposition of Device 4 4
Improper or Incorrect Procedure or Method 3 3
Overheating of Device 3 3
Device Handling Problem 3 3
No Apparent Adverse Event 3 3
Insufficient Information 3 3
Patient Device Interaction Problem 2 2
Device Fell 2 2
Smoking 2 2
Display or Visual Feedback Problem 2 2
Microbial Contamination of Device 2 2
Device Operates Differently Than Expected 2 2
Improper Device Output 2 2
Device Emits Odor 2 2
Melted 2 2
Fire 2 2
Loss of Power 1 1
Product Quality Problem 1 1
No Audible Prompt/Feedback 1 1
Defective Component 1 1
Difficult to Remove 1 1
Material Separation 1 1
Failure to Read Input Signal 1 1
Circuit Failure 1 1
Alarm Not Visible 1 1
Failure To Adhere Or Bond 1 1
Loss of or Failure to Bond 1 1
Material Fragmentation 1 1
Gas Output Problem 1 1
Insufficient Heating 1 1
Kinked 1 1
Loose or Intermittent Connection 1 1
Disconnection 1 1
Material Disintegration 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Sensing Problem 1 1
Device Dislodged or Dislocated 1 1
Electrical Shorting 1 1
Device Contamination with Chemical or Other Material 1 1
Free or Unrestricted Flow 1 1
Sticking 1 1
Connection Problem 1 1
Overfill 1 1
Excessive Heating 1 1
Noise, Audible 1 1
Unintended Movement 1 1
Optical Discoloration 1 1
Moisture or Humidity Problem 1 1
Naturally Worn 1 1
Physical Property Issue 1 1
Power Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2643 2718
No Clinical Signs, Symptoms or Conditions 623 623
Insufficient Information 315 315
No Known Impact Or Consequence To Patient 89 89
No Consequences Or Impact To Patient 31 31
Fall 10 10
Skull Fracture 6 6
Alteration in Body Temperature 3 3
No Code Available 2 2
Burn(s) 2 2
Inadequate Osseointegration 2 2
Thromboembolism 1 1
Alteration In Body Temperature 1 1
Injury 1 1
Fungal Infection 1 1
Partial thickness (Second Degree) Burn 1 1
No Information 1 1
Death 1 1
Edema 1 1
Swelling 1 1
Fever 1 1
Bone Fracture(s) 1 1
Hematoma 1 1
Hypothermia 1 1
Skin Discoloration 1 1
External Prosthetic Device Pain 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 GE Healthcare, LLC I Dec-03-2019
2 GE Healthcare, LLC I Jul-11-2019
3 GE Healthcare, LLC II Nov-19-2018
4 GE Healthcare, LLC II May-19-2017
5 GE Healthcare, LLC II Jan-11-2017
6 Ohmeda Medical II Mar-20-2017
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