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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
  1.  K230866  HotDog Warming Mattress + Return Electrode
  2.  K232627  HotDog Warming Mattress + Return Electrode
AUGUSTINE TEMPERATURE MANAGEMENT, LLC
  SUBSTANTIALLY EQUIVALENT 2
  1.  K230866  HotDog Warming Mattress + Return Electrode
  2.  K232627  HotDog Warming Mattress + Return Electrode
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 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

MDR Year MDR Reports MDR Events
2020 2546 2546
2021 2689 2694
2022 3226 3228
2023 3455 3461
2024 3329 3334
2025 2426 2427
2026 135 135

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Cooling 2699 2700
Failure to Pump 2360 2360
Device Sensing Problem 2219 2225
Defective Component 2165 2165
Inaccurate Flow Rate 1830 1830
Gas/Air Leak 1481 1481
Insufficient Heating 1458 1459
Restricted Flow rate 1154 1154
Decreased Pump Speed 1023 1023
Circuit Failure 762 762
Pumping Problem 630 630
Failure to Calibrate 522 522
Temperature Problem 487 489
Computer Operating System Problem 454 454
Nonstandard Device 367 367
Operating System Becomes Nonfunctional 355 355
Overheating of Device 346 346
Fluid/Blood Leak 253 253
Device Displays Incorrect Message 240 240
Material Fragmentation 217 217
Overfill 182 183
Improper or Incorrect Procedure or Method 182 182
Calibration Problem 176 176
Power Problem 161 161
Use of Device Problem 152 152
Device Alarm System 146 146
Therapeutic or Diagnostic Output Failure 119 120
Lack of Effect 117 117
Infusion or Flow Problem 114 114
Deformation Due to Compressive Stress 111 111
Fitting Problem 111 112
Adverse Event Without Identified Device or Use Problem 109 110
Material Split, Cut or Torn 101 101
Patient Device Interaction Problem 92 92
Alarm Not Visible 90 90
Material Separation 84 84
Biocompatibility 83 83
Display or Visual Feedback Problem 83 84
Insufficient Information 83 83
Computer Software Problem 79 79
Electrical Shorting 78 78
Device Handling Problem 76 76
Failure to Sense 73 74
Component Missing 69 69
No Flow 66 66
Misassembly by Users 66 66
Insufficient Flow or Under Infusion 59 59
Fracture 56 56
Filling Problem 52 52
Protective Measures Problem 51 51

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 14544 14558
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 1304 1305
No Patient Involvement 935 935
Chills 198 198
Insufficient Information 122 124
No Code Available 106 106
Patient Problem/Medical Problem 88 88
Burn(s) 85 85
Alteration In Body Temperature 77 77
Inadequate Pain Relief 51 51
Convulsion/Seizure 47 47
Skin Discoloration 43 43
Partial thickness (Second Degree) Burn 39 41
Blister 35 35
Skin Tears 31 31
Shaking/Tremors 27 27
Pressure Sores 23 23
Alteration in Body Temperature 20 20
Bradycardia 19 19
Fever 18 18
Skin Inflammation/ Irritation 17 17
Hypothermia 15 15
Paralysis 13 13
Superficial (First Degree) Burn 13 13
Full thickness (Third Degree) Burn 13 13
Discomfort 12 12
Erythema 12 13
No Information 12 12
Unspecified Infection 11 11
Pain 10 10
Sepsis 9 9
Low Blood Pressure/ Hypotension 9 9
Death 8 8
Seizures 8 8
Necrosis 8 8
Therapeutic Effects, Unexpected 7 7
Tissue Breakdown 6 6
Bacterial Infection 6 6
Sedation 5 5
Burn, Thermal 5 5
Rash 5 6
Burning Sensation 5 5
Localized Skin Lesion 4 4
Ischemia 4 4
Unspecified Tissue Injury 4 4
Emotional Changes 4 4
Skin Irritation 4 4
Electric Shock 4 4

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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