• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device warmer, infant radiant
Regulation Description Infant radiant warmer.
Product CodeFMT
Regulation Number 880.5130
Device Class 2


Premarket Reviews
ManufacturerDecision
DATEX OHMEDA INC.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
DRAEGER MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 1605 1605
2021 473 473
2022 153 153
2023 176 176
2024 257 257
2025 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Material Integrity Problem 1972 1972
Break 191 191
Pressure Problem 111 111
Crack 102 102
Insufficient Flow or Under Infusion 51 51
Device Alarm System 35 35
Nonstandard Device 32 32
Gas/Air Leak 21 21
Output Problem 21 21
No Audible Alarm 20 20
Incorrect, Inadequate or Imprecise Result or Readings 20 20
Fracture 18 18
Mechanical Problem 15 15
Detachment of Device or Device Component 14 14
Therapeutic or Diagnostic Output Failure 12 12
Device Sensing Problem 10 10
Microbial Contamination of Device 10 10
Product Quality Problem 8 8
Electrical /Electronic Property Problem 8 8
Contamination 8 8
Device Damaged Prior to Use 7 7
Smoking 6 6
Overheating of Device 6 6
Melted 6 6
No Flow 6 6
Defective Alarm 5 5
Fire 4 4
Loss of or Failure to Bond 4 4
Excessive Heating 4 4
Unable to Obtain Readings 4 4
Insufficient Information 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Infusion or Flow Problem 3 3
Temperature Problem 3 3
Unexpected Therapeutic Results 3 3
Loose or Intermittent Connection 3 3
Power Problem 3 3
No Apparent Adverse Event 3 3
Electrical Shorting 3 3
Thermal Decomposition of Device 3 3
Circuit Failure 3 3
Material Fragmentation 2 2
Device Dislodged or Dislocated 2 2
Suction Failure 2 2
Device Displays Incorrect Message 2 2
Protective Measures Problem 2 2
Structural Problem 2 2
Device Fell 2 2
Insufficient Heating 2 2
Failure to Sense 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 1188 1188
No Clinical Signs, Symptoms or Conditions 1100 1100
Insufficient Information 327 327
No Known Impact Or Consequence To Patient 28 28
Alteration in Body Temperature 10 10
Fall 6 6
Burn(s) 4 4
Skull Fracture 3 3
Low Oxygen Saturation 3 3
Superficial (First Degree) Burn 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Inadequate Osseointegration 2 2
Hyperthermia 2 2
No Consequences Or Impact To Patient 2 2
External Prosthetic Device Pain 1 1
Full thickness (Third Degree) Burn 1 1
Bone Fracture(s) 1 1
Fungal Infection 1 1
Bradycardia 1 1
Fever 1 1
Hemorrhage/Bleeding 1 1
Hypothermia 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Draeger Medical Systems, Inc. II Jun-22-2023
2 Wipro GE Healthcare Private Ltd. II Sep-20-2024
-
-