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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 2230 2232

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 2562 2562
Insufficient Cooling 2475 2475
Device Sensing Problem 2055 2055
Failure to Pump 1791 1791
Inaccurate Flow Rate 1603 1603
Gas/Air Leak 1346 1346
Insufficient Heating 1317 1317
Restricted Flow rate 999 999
Temperature Problem 930 930
Decreased Pump Speed 886 886
Circuit Failure 722 722
Pumping Problem 587 587
Failure to Calibrate 538 538
Device Displays Incorrect Message 499 499
Operating System Becomes Nonfunctional 356 356
Overheating of Device 308 308
Computer Operating System Problem 303 303
Nonstandard Device 229 229
Device Alarm System 215 215
Fluid/Blood Leak 213 213
Adverse Event Without Identified Device or Use Problem 194 194
Material Fragmentation 189 189
Improper or Incorrect Procedure or Method 182 182
Therapeutic or Diagnostic Output Failure 182 182
Infusion or Flow Problem 166 166
Display or Visual Feedback Problem 156 156
Protective Measures Problem 132 132
Overfill 132 132
No Flow 130 130
Use of Device Problem 122 122
Power Problem 120 120
Defective Device 111 111
Lack of Effect 97 97
Insufficient Flow or Under Infusion 97 97
Fitting Problem 92 92
Calibration Problem 90 90
Deformation Due to Compressive Stress 87 87
Computer Software Problem 82 82
Material Split, Cut or Torn 82 82
Biocompatibility 82 82
Filling Problem 80 80
Alarm Not Visible 76 76
Insufficient Information 71 71
Electrical Shorting 70 70
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Component Missing 68 68
Leak/Splash 66 68
No Display/Image 66 66
Break 61 61
Patient-Device Incompatibility 60 60

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 11070 11072
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 1215 1215
Alteration In Body Temperature 330 330
Patient Problem/Medical Problem 258 258
Chills 195 195
No Code Available 119 119
Insufficient Information 114 114
Inadequate Pain Relief 101 101
Burn(s) 72 72
Shaking/Tremors 55 55
Convulsion/Seizure 45 45
Partial thickness (Second Degree) Burn 44 44
Skin Discoloration 36 36
Death 34 34
No Information 32 32
Skin Tears 29 29
Blister 25 25
Hypothermia 25 25
Pressure Sores 21 21
Full thickness (Third Degree) Burn 18 18
Erythema 18 18
Therapeutic Effects, Unexpected 17 17
Seizures 17 17
Alteration in Body Temperature 17 17
Bradycardia 16 16
Discomfort 15 15
Burn, Thermal 15 15
Superficial (First Degree) Burn 15 15
Unspecified Infection 15 15
Skin Inflammation/ Irritation 14 14
Paralysis 14 14
Fever 14 14
Rash 13 13
Low Blood Pressure/ Hypotension 11 11
Sepsis 10 10
Skin Irritation 9 9
Necrosis 8 8
Cardiac Arrest 7 7
Swelling 6 6
Tissue Damage 5 5
Pain 5 5
Burning Sensation 5 5
Sedation 5 5
Unspecified Tissue Injury 4 4
Bacterial Infection 4 4
Localized Skin Lesion 4 4
Electric Shock 4 4

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