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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.
Definition If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Product CodeDWJ
Regulation Number 870.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
3M COMPANY
  SUBSTANTIALLY EQUIVALENT 1
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 7
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
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
TALLEY GROUP LTD.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No Known Device Problem 55
Unknown (for use when the device problem is not known) 44
Improper or incorrect procedure or method 31
No Information 31
Device operates differently than expected 26
Insufficient flow or underinfusion 23
Temperature issue 21
Material Protrusion 15
Smoking 15
Overheating of device or device component 14
Device displays error message 14
No code available 14
Fluid leak 10
Electrical issue 10
Intermittent continuity 8
Patient-device incompatibility 8
Improper flow or infusion 8
Infusion or flow issue 7
Not Applicable 7
Leak 7
Air leak 6
Output below specifications 5
Device alarm system issue 4
Device Cleaning Issue 4
Tubing, incorrect placement of 4
Use of Device Issue 4
Failure to power-up 3
Melted 3
Insufficient heating 3
Insufficient cooling 3
No display or display failure 3
Inaccurate flowrate 3
No flow 3
Torn material 2
Fire 2
Component(s), overheating of 2
Burn of device or device component 2
Method, improper/incorrect 2
Material separation 2
Fitting problem 1
Cut in material 1
Device emits odor 1
Loose or intermittent connection 1
Kinked 1
Fracture 1
Carbon absorption 1
Charred 1
Circuit Failure 1
Not audible alarm 1
Alarm, failure of warning 1
Break 1
Disconnection 1
Fail-safe design failure 1
Noise, Audible 1
Output issue 1
Therapeutic or diagnostic output failure 1
Inadequate user interface 1
Incompatibility problem 1
Component or accessory incompatibility 1
Difficult to open or close 1
Electrical overstress 1
Electrical shorting 1
Excessive cooling 1
Human-Device Interface Issue 1
Total Device Problems 453

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 2 5 4 2 3 0 3 2
Class III 0 0 0 0 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Arizant Inc II Mar-01-2010
2 C.R. Bard, Inc. II Aug-16-2017
3 C.R. Bard, Inc. III Aug-05-2016
4 C.R. Bard, Inc. II May-06-2016
5 C.R. Bard, Inc. II Apr-14-2016
6 C.R. Bard, Inc. II Feb-05-2016
7 Cincinnati Sub-Zero Products Inc II Jun-10-2014
8 Cincinnati Sub-Zero Products Inc II Dec-04-2013
9 Cincinnati Sub-Zero Products Inc II Sep-16-2013
10 Cincinnati Sub-Zero Products Inc II May-24-2012
11 Cincinnati Sub-Zero Products Inc II Feb-07-2012
12 Cincinnati Sub-Zero Products Inc II Sep-01-2011
13 Cincinnati Sub-Zero Products Inc II Jul-27-2011
14 Cincinnati Sub-Zero Products Inc II Jul-14-2011
15 Cincinnati Sub-Zero Products Inc II Jul-01-2011
16 Cincinnati Sub-Zero Products Inc II Mar-30-2011
17 Cincinnati Sub-Zero Products Inc II Feb-04-2010
18 Cincinnati Sub-Zero Products Inc II Oct-29-2009
19 Kimberly-Clark Corporation II Nov-29-2012
20 Kimberly-Clark Corporation II Aug-09-2012
21 Smiths Medical ASD, Inc. II May-22-2014
22 Stryker Medical Division of Stryker Corporation II May-10-2017
23 Stryker Medical Division of Stryker Corporation II Feb-05-2014

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