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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
Regulation Description Infant radiant warmer.
Product CodeFMT
Regulation Number 880.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 56 56
2017 46 46
2018 79 79
2019 1437 1512
2020 1605 1605
2021 419 419

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 3321 3395
Crack 103 103
Electrical /Electronic Property Problem 42 42
Nonstandard Device 32 32
No Audible Alarm 30 30
Break 29 29
Device Issue 26 26
Output Problem 21 21
Material Discolored 20 20
Incorrect, Inadequate or Imprecise Resultor Readings 19 19
Device Displays Incorrect Message 13 13
Device Alarm System 11 11
Therapeutic or Diagnostic Output Failure 9 9
Temperature Problem 8 8
Mechanical Problem 8 8
Detachment of Device or Device Component 7 7
Device Operates Differently Than Expected 7 7
Protective Measures Problem 6 7
Unable to Obtain Readings 6 6
Failure To Adhere Or Bond 5 5
Appropriate Term/Code Not Available 5 5
Use of Device Problem 5 5
Device Handling Problem 4 4
Thermal Decomposition of Device 4 4
Low Readings 4 4
Defective Component 2 2
Improper Device Output 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Device Fell 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
No Apparent Adverse Event 2 2
Insufficient Information 2 2
Physical Property Issue 2 2
Device Emits Odor 2 2
Overheating of Device 2 2
Melted 2 2
Fire 2 2
Display or Visual Feedback Problem 2 2
False Reading From Device Non-Compliance 1 1
Loss of or Failure to Bond 1 1
Loss of Power 1 1
Difficult to Remove 1 1
Microbial Contamination of Device 1 1
Failure to Deliver 1 1
Material Separation 1 1
Smoking 1 1
Overfill 1 1
Device Operational Issue 1 1
Device Dislodged or Dislocated 1 1
Infusion or Flow Problem 1 1
Optical Discoloration 1 1
Noise, Audible 1 1
Patient Device Interaction Problem 1 1
Device Damaged Prior to Use 1 1
Failure to Read Input Signal 1 1
Sticking 1 1
Connection Problem 1 1
Device Sensing Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Free or Unrestricted Flow 1 1
Kinked 1 1
Alarm Not Visible 1 1
Excessive Heating 1 1
Unintended Movement 1 1
Mechanics Altered 1 1
Moisture or Humidity Problem 1 1
Compatibility Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 2665 2740
No Clinical Signs, Symptoms or Conditions 498 498
Insufficient Information 298 298
No Known Impact Or Consequence To Patient 107 107
No Consequences Or Impact To Patient 42 42
Fall 7 7
Skull Fracture 6 6
Burn(s) 4 4
Hypothermia 3 3
No Information 3 3
No Code Available 3 3
Alteration in Body Temperature 2 2
Inadequate Osseointegration 2 2
Thromboembolism 1 1
Alteration In Body Temperature 1 1
Tachycardia 1 1
Injury 1 1
Death 1 1
Edema 1 1
External Prosthetic Device Pain 1 1
Skin Discoloration 1 1
Swelling 1 1
Fever 1 1
Hematoma 1 1
Partial thickness (Second Degree) Burn 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical, Inc. II Jul-28-2016
2 GE Healthcare, LLC I Dec-03-2019
3 GE Healthcare, LLC I Jul-11-2019
4 GE Healthcare, LLC II Nov-19-2018
5 GE Healthcare, LLC II May-19-2017
6 GE Healthcare, LLC II Jan-11-2017
7 Ohmeda Medical II Mar-20-2017
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