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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 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 1
ENCOMPASS GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
HADLEIGH HEALTH TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
IOB MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 3
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
2020 2546 2546
2021 2689 2689
2022 3226 3226
2023 3464 3464
2024 3330 3332
2025 1322 1322

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Cooling 2523 2523
Failure to Pump 2090 2090
Device Sensing Problem 2040 2040
Defective Component 2015 2015
Inaccurate Flow Rate 1682 1682
Gas/Air Leak 1429 1429
Insufficient Heating 1382 1382
Restricted Flow rate 1060 1060
Decreased Pump Speed 985 985
Circuit Failure 721 721
Pumping Problem 617 617
Failure to Calibrate 522 522
Temperature Problem 483 483
Computer Operating System Problem 399 399
Operating System Becomes Nonfunctional 355 355
Overheating of Device 318 318
Nonstandard Device 244 244
Device Displays Incorrect Message 240 240
Fluid/Blood Leak 229 229
Material Fragmentation 205 205
Improper or Incorrect Procedure or Method 178 178
Overfill 156 156
Power Problem 150 150
Device Alarm System 144 144
Calibration Problem 139 139
Use of Device Problem 134 134
Therapeutic or Diagnostic Output Failure 119 119
Infusion or Flow Problem 113 113
Lack of Effect 113 113
Adverse Event Without Identified Device or Use Problem 106 106
Deformation Due to Compressive Stress 105 105
Fitting Problem 102 102
Material Split, Cut or Torn 91 91
Patient Device Interaction Problem 86 86
Alarm Not Visible 85 85
Biocompatibility 83 83
Display or Visual Feedback Problem 83 83
Electrical Shorting 76 76
Insufficient Information 76 76
Device Handling Problem 70 70
Computer Software Problem 70 70
No Flow 66 66
Component Missing 66 66
Misassembly by Users 64 64
Failure to Sense 61 61
Insufficient Flow or Under Infusion 58 58
Material Separation 55 55
Filling Problem 52 52
Fracture 51 51
Protective Measures Problem 51 51

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13352 13354
No Consequences Or Impact To Patient 1381 1381
No Known Impact Or Consequence To Patient 1380 1380
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1279 1279
No Patient Involvement 935 935
Chills 194 194
Insufficient Information 120 120
No Code Available 106 106
Patient Problem/Medical Problem 88 88
Burn(s) 82 82
Alteration In Body Temperature 77 77
Inadequate Pain Relief 51 51
Convulsion/Seizure 47 47
Skin Discoloration 39 39
Partial thickness (Second Degree) Burn 36 36
Blister 35 35
Skin Tears 30 30
Shaking/Tremors 27 27
Pressure Sores 22 22
Alteration in Body Temperature 20 20
Bradycardia 18 18
Fever 17 17
Skin Inflammation/ Irritation 16 16
Hypothermia 15 15
Paralysis 13 13
Superficial (First Degree) Burn 13 13
No Information 12 12
Erythema 12 12
Full thickness (Third Degree) Burn 12 12
Discomfort 11 11
Unspecified Infection 11 11
Pain 9 9
Sepsis 9 9
Low Blood Pressure/ Hypotension 9 9
Necrosis 8 8
Seizures 8 8
Death 8 8
Therapeutic Effects, Unexpected 7 7
Bacterial Infection 6 6
Rash 5 5
Burning Sensation 5 5
Burn, Thermal 5 5
Sedation 5 5
Localized Skin Lesion 4 4
Unspecified Tissue Injury 4 4
Skin Irritation 4 4
Electric Shock 4 4
Tissue Breakdown 4 4
Hyperthermia 3 3
Abrasion 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Augustine Temperature Management, LLC II Feb-20-2025
2 Augustine Temperature Management, LLC II Feb-14-2025
3 Augustine Temperature Management, LLC II Jan-10-2025
4 Augustine Temperature Management, LLC II Dec-18-2024
5 Belmont Instrument Corporation II Oct-31-2022
6 Belmont Instrument LLC II Jun-12-2025
7 Care Essentials Pty., Ltd. II Mar-03-2020
8 Medivance Inc. II Jul-31-2024
9 Medivance Inc. II Mar-26-2024
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