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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 2
AUGUSTINE TEMPERATURE MANAGEMENT
  SUBSTANTIALLY EQUIVALENT 2
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
  SUBSTANTIALLY EQUIVALENT 2
BRAINCOOL AB
  SUBSTANTIALLY EQUIVALENT 1
CARE ESSENTIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 2
ENCOMPASS GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
IOB MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 4
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES LP
  SUBSTANTIALLY EQUIVALENT 1
MOLNLYCKE HEALTH CARE US, LLC
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2294 2294
2020 2546 2546
2021 2689 2689
2022 3226 3226
2023 3464 3464
2024 3330 3332

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 2663 2663
Insufficient Cooling 2641 2641
Device Sensing Problem 2187 2187
Failure to Pump 1888 1888
Inaccurate Flow Rate 1740 1740
Gas/Air Leak 1431 1431
Insufficient Heating 1415 1415
Restricted Flow rate 1092 1092
Temperature Problem 934 934
Decreased Pump Speed 923 923
Circuit Failure 764 764
Pumping Problem 617 617
Failure to Calibrate 539 539
Device Displays Incorrect Message 499 499
Computer Operating System Problem 360 360
Operating System Becomes Nonfunctional 356 356
Overheating of Device 330 330
Fluid/Blood Leak 241 241
Nonstandard Device 237 237
Device Alarm System 222 222
Material Fragmentation 198 198
Adverse Event Without Identified Device or Use Problem 194 194
Improper or Incorrect Procedure or Method 191 191
Therapeutic or Diagnostic Output Failure 182 182
Infusion or Flow Problem 166 166
Display or Visual Feedback Problem 156 156
Overfill 139 139
Power Problem 136 136
Use of Device Problem 135 135
Protective Measures Problem 132 132
No Flow 130 130
Calibration Problem 127 127
Defective Device 112 112
Lack of Effect 104 104
Fitting Problem 101 101
Insufficient Flow or Under Infusion 97 97
Deformation Due to Compressive Stress 96 96
Material Split, Cut or Torn 92 92
Computer Software Problem 83 83
Biocompatibility 82 82
Alarm Not Visible 81 81
Filling Problem 80 80
Insufficient Information 79 79
Electrical Shorting 79 79
Incorrect, Inadequate or Imprecise Result or Readings 70 70
Patient Device Interaction Problem 69 69
No Display/Image 69 69
Component Missing 68 68
Leak/Splash 66 68
Device Handling Problem 64 64

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 12123 12125
No Known Impact Or Consequence To Patient 2851 2851
No Consequences Or Impact To Patient 2626 2626
No Patient Involvement 1585 1585
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1250 1250
Alteration In Body Temperature 330 330
Patient Problem/Medical Problem 258 258
Chills 202 202
No Code Available 119 119
Insufficient Information 115 115
Inadequate Pain Relief 101 101
Burn(s) 76 76
Shaking/Tremors 55 55
Convulsion/Seizure 46 46
Partial thickness (Second Degree) Burn 44 44
Skin Discoloration 39 39
Death 34 34
No Information 32 32
Skin Tears 29 29
Blister 28 28
Hypothermia 25 25
Pressure Sores 21 21
Erythema 20 20
Bradycardia 19 19
Full thickness (Third Degree) Burn 19 19
Alteration in Body Temperature 18 18
Seizures 17 17
Therapeutic Effects, Unexpected 17 17
Fever 16 16
Burn, Thermal 15 15
Discomfort 15 15
Superficial (First Degree) Burn 15 15
Unspecified Infection 15 15
Skin Inflammation/ Irritation 14 14
Paralysis 14 14
Rash 13 13
Low Blood Pressure/ Hypotension 11 11
Sepsis 10 10
Skin Irritation 9 9
Necrosis 9 9
Cardiac Arrest 7 7
Swelling 6 6
Burning Sensation 6 6
Tissue Damage 5 5
Sedation 5 5
Pain 5 5
Electric Shock 5 5
Unspecified Tissue Injury 4 4
Respiratory Distress 4 4
Bacterial Infection 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Augustine Temperature Management, LLC II Jan-10-2025
2 Augustine Temperature Management, LLC II Dec-18-2024
3 Bard Medical Division II Apr-27-2019
4 Belmont Instrument Corporation II Oct-31-2022
5 Care Essentials Pty., Ltd. II Mar-03-2020
6 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Nov-18-2019
7 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Sep-04-2019
8 Medivance Inc. II Jul-31-2024
9 Medivance Inc. II Mar-26-2024
10 Pintler Medical LLC II Apr-12-2019
11 Tec Com Gmbh II Nov-12-2019
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