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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
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 3
AUGUSTINE BIOMEDICAL & DESIGN, LLC
  SUBSTANTIALLY EQUIVALENT 3
AUGUSTINE TEMPERATURE MANAGEMENT
  SUBSTANTIALLY EQUIVALENT 2
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
  SUBSTANTIALLY EQUIVALENT 2
BCG MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BRAIN COOL AB
  SUBSTANTIALLY EQUIVALENT 1
BRAINCOOL AB
  SUBSTANTIALLY EQUIVALENT 1
CARE ESSENTIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 3
CINCINNATI SUB-ZERO PRODUCTS, INC
  SUBSTANTIALLY EQUIVALENT 2
CINCINNATI SUB-ZERO PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 2
ENCOMPASS GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
GALMAZ BIOTECH S.L.
  SUBSTANTIALLY EQUIVALENT 1
GAYMAR INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
GERATHERM MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 2
INSPIRATION HEALTHCARE LTD
  SUBSTANTIALLY EQUIVALENT 1
IOB MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 5
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDLINE INDUSTRIES LP
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 2
MTRE ADVANCED TECHNOLOGY LTD.
  SUBSTANTIALLY EQUIVALENT 2
PINTLER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SMITH MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 2
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
THE SURGICAL COMPANY INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 1
THE SURGICAL COMPANY INTERNATIONAL BV (AS THE 37COMPANY)
  SUBSTANTIALLY EQUIVALENT 1
VITAHEAT MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
WELKINS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 116 116
2015 245 245
2016 1401 1401
2017 1473 1473
2018 1517 1517
2019 2294 2294
2020 2546 2546
2021 2689 2689
2022 3226 3226
2023 3464 3464
2024 1484 1484

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 2955 2955
Insufficient Cooling 2682 2682
Device Sensing Problem 2202 2202
Temperature Problem 1791 1791
Inaccurate Flow Rate 1726 1726
Failure to Pump 1679 1679
Device Displays Incorrect Message 1476 1476
Insufficient Heating 1418 1418
Gas/Air Leak 1315 1315
Restricted Flow rate 1058 1058
Decreased Pump Speed 849 849
Circuit Failure 730 730
Pumping Problem 628 628
Failure to Calibrate 554 554
Device Operates Differently Than Expected 550 550
Adverse Event Without Identified Device or Use Problem 360 360
Operating System Becomes Nonfunctional 356 356
Overheating of Device 353 353
Microbial Contamination of Device 332 332
Computer Operating System Problem 315 315
Insufficient Flow or Under Infusion 314 314
No Flow 292 292
Fluid/Blood Leak 280 280
Infusion or Flow Problem 266 266
Nonstandard Device 259 259
Improper or Incorrect Procedure or Method 255 255
Device Alarm System 253 253
Product Quality Problem 244 244
Insufficient Information 203 203
Contamination 196 196
Therapeutic or Diagnostic Output Failure 194 194
Display or Visual Feedback Problem 192 192
Material Fragmentation 174 174
Leak/Splash 172 172
Use of Device Problem 156 156
Filling Problem 145 145
Defective Device 145 145
Air Leak 143 143
Protective Measures Problem 135 135
Overfill 131 131
Power Problem 122 122
Patient-Device Incompatibility 112 112
No Display/Image 111 111
Break 111 111
Improper Flow or Infusion 111 111
Fitting Problem 99 99
Computer Software Problem 97 97
Appropriate Term/Code Not Available 88 88
Deformation Due to Compressive Stress 86 86
Incorrect, Inadequate or Imprecise Result or Readings 85 85
Lack of Effect 82 82
Biocompatibility 81 81
Component Missing 79 79
Material Split, Cut or Torn 79 79
Alarm Not Visible 70 70
Noise, Audible 68 68
Calibration Problem 67 67
Electrical Shorting 67 67
Loss of Power 64 64
Device Inoperable 64 64
Misassembly by Users 59 59
Output Problem 58 58
Failure to Sense 55 55
Device Handling Problem 53 53
Patient Device Interaction Problem 53 53
Material Separation 51 51
Fracture 47 47
Material Twisted/Bent 46 46
Excessive Heating 45 45
Failure to Power Up 44 44
Output below Specifications 44 44
Erratic or Intermittent Display 43 43
Contamination /Decontamination Problem 42 42
Electrical /Electronic Property Problem 39 39
Excessive Cooling 39 39
Device Dislodged or Dislocated 38 38
Pressure Problem 37 37
Device Emits Odor 35 35
Partial Blockage 33 33
Physical Resistance/Sticking 28 28
Unable to Obtain Readings 28 28
Material Protrusion/Extrusion 27 27
Thermal Decomposition of Device 26 26
Suction Problem 24 24
Component Misassembled 24 24
Loss of or Failure to Bond 23 23
Disconnection 23 23
Naturally Worn 23 23
No Apparent Adverse Event 21 21
Short Fill 20 20
Loose or Intermittent Connection 19 19
Smoking 19 19
Melted 19 19
Connection Problem 19 19
Unexpected Therapeutic Results 18 18
Improper Device Output 18 18
Solder Joint Fracture 18 18
Failure of Device to Self-Test 18 18
Moisture Damage 16 16
Device Disinfection Or Sterilization Issue 15 15

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10362 10362
No Known Impact Or Consequence To Patient 4983 4983
No Consequences Or Impact To Patient 3577 3577
No Patient Involvement 2048 2048
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1193 1193
Alteration In Body Temperature 930 930
Patient Problem/Medical Problem 366 366
Unspecified Infection 364 365
No Information 331 331
No Code Available 222 222
Chills 199 199
Post Operative Wound Infection 167 167
Death 156 156
Burn(s) 152 152
Inadequate Pain Relief 119 119
Injury 114 114
Insufficient Information 110 110
Bacterial Infection 103 104
Partial thickness (Second Degree) Burn 96 96
Shaking/Tremors 84 84
Therapeutic Effects, Unexpected 69 69
Hypothermia 66 66
Erythema 53 53
Skin Discoloration 53 53
Skin Tears 47 47
Burn, Thermal 44 44
Convulsion/Seizure 44 44
Superficial (First Degree) Burn 43 43
Fever 43 43
Cardiac Arrest 37 37
Ambulation Difficulties 37 37
Pain 35 35
Seizures 35 35
Swelling 32 32
Tissue Damage 30 30
Staphylococcus Aureus 28 28
Pressure Sores 28 28
Full thickness (Third Degree) Burn 28 28
Skin Irritation 25 25
Bradycardia 24 24
Blister 23 23
Rash 22 22
Sepsis 20 20
Discomfort 18 18
Low Blood Pressure/ Hypotension 17 17
Alteration in Body Temperature 16 16
Limited Mobility Of The Implanted Joint 15 15
Therapeutic Response, Decreased 15 15
Paralysis 15 15
Pneumonia 14 14
Necrosis 13 13
Hyperthermia 13 13
Skin Inflammation/ Irritation 13 13
Complaint, Ill-Defined 12 12
Not Applicable 10 10
Burning Sensation 9 9
Respiratory Distress 9 9
Edema 9 9
Bruise/Contusion 8 8
High Blood Pressure/ Hypertension 8 8
Brain Injury 8 8
Respiratory Failure 7 7
Twitching 7 7
Tissue Breakdown 7 7
Electric Shock 6 6
Hypoxia 6 6
Cardiopulmonary Arrest 6 6
Abrasion 5 5
Hemorrhage/Bleeding 5 5
Pulmonary Edema 5 5
Irritation 5 5
Ischemia 5 5
Cardiogenic Shock 5 5
Sedation 5 5
Disability 5 5
Tachycardia 5 5
Skin Inflammation 5 5
Localized Skin Lesion 4 4
Unspecified Tissue Injury 4 4
Septic Shock 4 4
Loss of consciousness 4 4
Underdose 3 3
Ulcer 3 3
Scar Tissue 3 3
Chronic Obstructive Pulmonary Disease (COPD) 3 3
Myocardial Infarction 3 3
Peeling 3 3
Hematoma 3 3
Ecchymosis 3 3
Emotional Changes 3 3
Test Result 3 3
Multiple Organ Failure 3 3
Sweating 3 3
Fluid Discharge 3 3
Foreign Body In Patient 2 2
Confusion/ Disorientation 2 2
Chemical Exposure 2 2
Blood Loss 2 2
Skin Infection 2 2
Pulmonary Emphysema 2 2

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Feb-12-2018
2 Arizant Inc II Mar-01-2010
3 Bard Medical Division II Apr-27-2019
4 Bard Medical Division II Jul-24-2018
5 Belmont Instrument Corporation II Oct-31-2022
6 C.R. Bard, Inc. III Feb-12-2018
7 C.R. Bard, Inc. II Dec-20-2017
8 C.R. Bard, Inc. II Aug-16-2017
9 C.R. Bard, Inc. III Aug-05-2016
10 C.R. Bard, Inc. II May-06-2016
11 C.R. Bard, Inc. II Apr-14-2016
12 C.R. Bard, Inc. II Feb-05-2016
13 Care Essentials Pty., Ltd. II Mar-03-2020
14 Cincinnati Sub-Zero Products Inc II Jun-10-2014
15 Cincinnati Sub-Zero Products Inc II Dec-04-2013
16 Cincinnati Sub-Zero Products Inc II Sep-16-2013
17 Cincinnati Sub-Zero Products Inc II May-24-2012
18 Cincinnati Sub-Zero Products Inc II Feb-07-2012
19 Cincinnati Sub-Zero Products Inc II Sep-01-2011
20 Cincinnati Sub-Zero Products Inc II Jul-27-2011
21 Cincinnati Sub-Zero Products Inc II Jul-14-2011
22 Cincinnati Sub-Zero Products Inc II Jul-01-2011
23 Cincinnati Sub-Zero Products Inc II Mar-30-2011
24 Cincinnati Sub-Zero Products Inc II Feb-04-2010
25 Cincinnati Sub-Zero Products Inc II Oct-29-2009
26 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Nov-18-2019
27 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Sep-04-2019
28 Kimberly-Clark Corporation II Nov-29-2012
29 Kimberly-Clark Corporation II Aug-09-2012
30 Medivance Inc. II Mar-26-2024
31 Medtronic Perfusion Systems II Mar-06-2018
32 Pintler Medical LLC II Apr-12-2019
33 Smiths Medical ASD, Inc. II May-22-2014
34 Stryker Medical Division of Stryker Corporation II Oct-24-2018
35 Stryker Medical Division of Stryker Corporation II Jan-27-2018
36 Stryker Medical Division of Stryker Corporation II May-10-2017
37 Stryker Medical Division of Stryker Corporation II Feb-05-2014
38 Tec Com Gmbh II Nov-12-2019
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