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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
  SUBSTANTIALLY EQUIVALENT 2
DEROYAL INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
INTERNATIONAL BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
INTERNATIONAL BIOMEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material Integrity Problem 2109
Crack 70
Electrical /Electronic Property Problem 38
Device Issue 27
No Audible Alarm 26
Break 9
Output Problem 7
Incorrect, Inadequate or Imprecise Result or Readings 6
Device Alarm System 6
Failure To Adhere Or Bond 5
Device Displays Incorrect Message 5
Protective Measures Problem 5
Appropriate Term/Code Not Available 5
Low Readings 4
Adverse Event Without Identified Device or Use Problem 3
Mechanical Problem 3
Use of Device Problem 3
Device Handling Problem 3
Improper Device Output 2
Physical Property Issue 2
Detachment of Device or device Component 2
Thermal Decomposition of Device 2
Unable to Obtain Readings 2
No Apparent Adverse Event 2
Display or Visual Feedback Problem 2
Device Maintenance Issue 1
Connection Problem 1
Device Operational Issue 1
Infusion or Flow Problem 1
Alarm Not Visible 1
Manufacturing, Packaging or Shipping Problem 1
Loss of or Failure to Bond 1
Transport 1
Insufficient Information 1
Patient Device Interaction Problem 1
Device Fell 1
Device Dislodged or Dislocated 1
Unintended Movement 1
Product Quality Problem 1
Overfill 1
Free or Unrestricted Flow 1
Total Device Problems 2364

Recalls
Manufacturer Recall Class Date Posted
1 DeRoyal Industries Inc II Nov-30-2015
2 Draeger Medical, Inc. II Jul-28-2016
3 GE Healthcare, LLC I Dec-03-2019
4 GE Healthcare, LLC I Jul-11-2019
5 GE Healthcare, LLC II Nov-19-2018
6 GE Healthcare, LLC II May-19-2017
7 GE Healthcare, LLC II Jan-11-2017
8 Ohmeda Medical II Mar-20-2017

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