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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, thermal regulating
Regulation Description Thermal regulating system.
Product CodeDWJ
Regulation Number 870.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
ADROIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
AMERICAN HEALTHCARE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ARIZANT HEALTHCARE INC.
  SUBSTANTIALLY EQUIVALENT 3
AUGUSTINE MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 12
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
CINCINNATI SUB-ZERO PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 11
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
DYNATHERM MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 6
GERATHERM MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
GVP ELETTRONICA SRL
  SUBSTANTIALLY EQUIVALENT 1
HILL-ROM, INC.
  SUBSTANTIALLY EQUIVALENT 1
INDITHERM MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
KIMBERLY-CLARK CORP.
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MARQUEST MEDICAL PRODUCTS INC
  SUBSTANTIALLY EQUIVALENT 1
MEDCOOL INC
  SUBSTANTIALLY EQUIVALENT 1
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 6
MICROTEK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MTRE ADVANCED TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 6
NELLCOR PURITAN BENNETT
  SUBSTANTIALLY EQUIVALENT 2
SEABROOK MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
SIMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 4
TALLEY GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 53
Unknown (for use when the device problem is not known) 44
Insufficient flow or underinfusion 23
Device operates differently than expected 17
Temperature issue 16
No Information 16
Material Protrusion 15
Device displays error message 14
Smoking 13
Overheating of device or device component 13
Fluid leak 10
Patient-device incompatibility 8
Improper flow or infusion 8
Infusion or flow issue 7
Leak 7
Intermittent continuity 7
Electrical issue 7
Air leak 6
Output below specifications 5
Not Applicable 5
Tubing, incorrect placement of 4
Use of Device Issue 4
Insufficient heating 3
Failure to power-up 3
Melted 3
Insufficient cooling 3
No display or display failure 3
No code available 3
No flow 3
Torn material 2
Component(s), overheating of 2
Fire 2
Inaccurate flowrate 2
Device alarm system issue 2
Method, improper/incorrect 2
Material separation 2
Improper or incorrect procedure or method 2
Fitting problem 1
Cut in material 1
Device emits odor 1
Loose or intermittent connection 1
Not audible alarm 1
Alarm, failure of warning 1
Break 1
Carbon absorption 1
Charred 1
Circuit Failure 1
Fail-safe design failure 1
Disconnection 1
Therapeutic or diagnostic output failure 1
Output issue 1
Inadequate user interface 1
Incompatibility problem 1
Component or accessory incompatibility 1
Difficult to open or close 1
Electrical overstress 1
Excessive cooling 1
Human-Device Interface Issue 1
Total Device Problems 360

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 2 5 4 2 3 0 3
Class III 0 0 0 0 0 0 0 0 0 1

Recalls
Manufacturer Recall Class Date Posted
1 Arizant Inc II Mar-01-2010
2 C.R. Bard, Inc. III Aug-05-2016
3 C.R. Bard, Inc. II May-06-2016
4 C.R. Bard, Inc. II Apr-14-2016
5 C.R. Bard, Inc. II Feb-05-2016
6 Cincinnati Sub-Zero Products Inc II Jun-10-2014
7 Cincinnati Sub-Zero Products Inc II Dec-04-2013
8 Cincinnati Sub-Zero Products Inc II Sep-16-2013
9 Cincinnati Sub-Zero Products Inc II May-24-2012
10 Cincinnati Sub-Zero Products Inc II Feb-07-2012
11 Cincinnati Sub-Zero Products Inc II Sep-01-2011
12 Cincinnati Sub-Zero Products Inc II Jul-27-2011
13 Cincinnati Sub-Zero Products Inc II Jul-14-2011
14 Cincinnati Sub-Zero Products Inc II Jul-01-2011
15 Cincinnati Sub-Zero Products Inc II Mar-30-2011
16 Cincinnati Sub-Zero Products Inc II Feb-04-2010
17 Cincinnati Sub-Zero Products Inc II Oct-29-2009
18 Kimberly-Clark Corporation II Nov-29-2012
19 Kimberly-Clark Corporation II Aug-09-2012
20 Smiths Medical ASD, Inc. II May-22-2014
21 Stryker Medical Division of Stryker Corporation II Feb-05-2014

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