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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
ARAGON SURGICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
ATOM MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 3
CAS MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
DRAEGER MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 5
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
  1.  K812745  WARMING LISTHTS #96H & 96HT
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIX I.C.S.A.
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
VERMONT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Crack 22
Break 7
Device Issue 5
Device alarm system issue 4
Not audible alarm 4
No Known Device Problem 3
Device displays error message 2
Burn of device or device component 2
Device Cleaning Issue 2
Detachment of device component 2
Material disintegration 2
Incorrect display 1
Fire 1
Insufficient heating 1
Leak 1
Device maintenance issue 1
Overheating of device or device component 1
Slippage of device or device component 1
Sticking 1
Device inoperable 1
Component falling 1
Material discolored 1
Malposition of device 1
Device misassembled during manufacturing or shipping 1
Device operates differently than expected 1
Medical Gas Supply problem 1
Temperature issue 1
No code available 1
Device handling issue 1
High Readings 1
Total Device Problems 74

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 0 0 0 0 0 0
Class II 1 1 1 0 0 0 0 3 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Datex Ohmeda, Inc. dba GE Healthcare II Sep-11-2008
2 DeRoyal Industries Inc II Nov-30-2015
3 Draeger Medical Systems, Inc. II Aug-26-2009
4 Draeger Medical Systems, Inc. I Aug-25-2009
5 Fisher & Paykel Healthcare Ltd II Jan-11-2007
6 Fisher & Paykel Healthcare, Ltd. II Nov-13-2014
7 GE Healthcare II May-06-2014
8 GE Healthcare II Feb-03-2014

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