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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
KINETIC CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDIX I.C.S.A.
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 10
  1.  K070377  GIRAFFE AND PANDA WARMER
  2.  K072157  MODIFICATION TO GIRAFFE AND PANDA WARMERS (GIRAFFE ...
  3.  K090697  MODIFICATION TO: GIRAFFE AND PANDA WARMER
  4.  K123309  GIRAFFE AND PANDA WARMERS
  5.  K851449  OHMEDA 5000 INFANT WARMER SYSTEM
  6.  K853351  OHMEDA HEAT REFLECTING PATCH
  7.  K863208  OHMEDA AUXILIARY POWER SYSTEM
  8.  K884160  OHMEDA - OHIO(R) 3500 INFANT WARMER SYSTEM
  9.  K921766  OHIO INFANT WARMER SYSTEM
  10.  K963058  INFANT WARMER SYSTEM
SAGE PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
VERMONT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Crack 23
Break 7
Device Issue 6
Not audible alarm 5
Device alarm system issue 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 77

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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