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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 2
ENCOMPASS GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
HADLEIGH HEALTH TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU TAPPA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IOB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
XODUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2294 2295
2020 2546 2546
2021 2689 2694
2022 3226 3228
2023 3455 3461
2024 3329 3334
2025 2430 2431
2026 871 871

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 2912 2912
Insufficient Cooling 2836 2837
Failure to Pump 2558 2558
Device Sensing Problem 2498 2503
Inaccurate Flow Rate 2073 2073
Insufficient Heating 1542 1543
Gas/Air Leak 1504 1504
Restricted Flow rate 1314 1314
Decreased Pump Speed 1048 1048
Circuit Failure 865 865
Pumping Problem 639 639
Nonstandard Device 528 528
Computer Operating System Problem 487 487
Failure to Calibrate 483 483
Operating System Becomes Nonfunctional 356 356
Overheating of Device 347 347
Fluid/Blood Leak 246 246
Material Fragmentation 216 216
Calibration Problem 206 206
Use of Device Problem 197 197
Improper or Incorrect Procedure or Method 193 193
Overfill 186 187
Power Problem 170 170
Fitting Problem 121 122
Lack of Effect 119 119
Deformation Due to Compressive Stress 113 113
Temperature Problem 102 102
Patient Device Interaction Problem 99 99
Material Split, Cut or Torn 98 98
Insufficient Device Problem Information 95 95
Alarm Not Visible 90 90
Material Separation 90 90
Computer Software Problem 87 87
Failure to Sense 83 84
Electrical Shorting 81 81
Biocompatibility 81 81
Device Alarm System 78 78
Device Handling Problem 76 76
Misassembly by Users 67 67
Component Missing 60 60
Fracture 57 57
Excessive Heating 49 49
Patient-Device Incompatibility 42 42
Noise, Audible 41 41
Erratic or Intermittent Display 40 44
Adverse Event Without Identified Device or Use Problem 39 39
Partial Blockage 35 35
Component Misassembled 35 35
Loss of or Failure to Bond 32 32
Material Twisted/Bent 31 31

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15248 15262
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 and Conditions Term/Code Not Available 1316 1317
Alteration In Body Temperature 330 330
Patient Problem/Medical Problem 258 258
Chills 215 215
Insufficient Information 126 128
No Code Available 119 119
Burn(s) 107 107
Inadequate Pain Relief 101 101
Partial thickness (Second Degree) Burn 61 64
Shaking/Tremors 55 55
Skin Discoloration 49 49
Convulsion/Seizure 48 48
Blister 39 39
Skin Tears 38 38
Death 34 34
No Information 32 32
Hypothermia 25 25
Pressure Sore/Ulcer 25 25
Full thickness (Third Degree) Burn 24 24
Fever 24 24
Erythema 23 24
Bradycardia 21 21
Alteration in Body Temperature 20 20
Discomfort 19 19
Superficial (First Degree) Burn 18 18
Skin Inflammation/ Irritation 17 17
Seizures 17 17
Therapeutic Effects, Unexpected 17 17
Unspecified Infection 15 15
Burn, Thermal 15 15
Paralysis 14 14
Sepsis 13 13
Rash 13 14
Pain 13 13
Low Blood Pressure/ Hypotension 11 11
Necrosis 11 11
Skin Irritation 9 9
Bacterial Infection 7 7
Cardiac Arrest 7 7
Swelling 6 6
Electric Shock 6 6
Tissue Breakdown 6 6
Peeling 6 6
Burning Sensation 6 6
Tissue Damage 5 5
Ischemia 5 5

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 Bard Medical Division II Apr-27-2019
6 Belmont Instrument Corporation II Oct-31-2022
7 Belmont Instrument LLC II Jun-12-2025
8 Care Essentials Pty., Ltd. II Mar-03-2020
9 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Nov-18-2019
10 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Sep-04-2019
11 Medivance Inc. II Jul-31-2024
12 Medivance Inc. II Mar-26-2024
13 Pintler Medical LLC II Apr-12-2019
14 Tec Com Gmbh II Nov-12-2019
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