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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
ZOLL CIRCULATION, INC
  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 883 883

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 2365 2365
Insufficient Cooling 2283 2283
Device Sensing Problem 1913 1913
Failure to Pump 1576 1576
Inaccurate Flow Rate 1453 1453
Gas/Air Leak 1248 1248
Insufficient Heating 1222 1222
Restricted Flow rate 921 921
Temperature Problem 917 917
Decreased Pump Speed 816 816
Circuit Failure 657 657
Pumping Problem 528 528
Failure to Calibrate 514 514
Device Displays Incorrect Message 497 497
Operating System Becomes Nonfunctional 347 347
Overheating of Device 287 287
Computer Operating System Problem 267 267
Nonstandard Device 226 226
Device Alarm System 203 203
Fluid/Blood Leak 198 198
Adverse Event Without Identified Device or Use Problem 193 193
Therapeutic or Diagnostic Output Failure 182 182
Improper or Incorrect Procedure or Method 167 167
Infusion or Flow Problem 166 166
Material Fragmentation 161 161
Display or Visual Feedback Problem 154 154
Protective Measures Problem 132 132
No Flow 129 129
Power Problem 114 114
Overfill 113 113
Use of Device Problem 111 111
Defective Device 110 110
Insufficient Flow or Under Infusion 97 97
Fitting Problem 90 90
Deformation Due to Compressive Stress 81 81
Computer Software Problem 81 81
Filling Problem 80 80
Biocompatibility 80 80
Material Split, Cut or Torn 75 75
Incorrect, Inadequate or Imprecise Result or Readings 69 69
Component Missing 67 67
Insufficient Information 66 66
Electrical Shorting 63 63
Lack of Effect 63 63
No Display/Image 62 62
Leak/Splash 62 62
Patient-Device Incompatibility 60 60
Break 59 59
Misassembly by Users 57 57
Device Handling Problem 51 51
Failure to Sense 50 50
Noise, Audible 45 45
Improper Flow or Infusion 45 45
Output Problem 45 45
Material Twisted/Bent 44 44
Patient Device Interaction Problem 44 44
Fracture 43 43
Alarm Not Visible 41 41
Excessive Heating 41 41
Material Separation 38 38
Calibration Problem 35 35
Erratic or Intermittent Display 34 34
Appropriate Term/Code Not Available 34 34
Device Dislodged or Dislocated 30 30
Partial Blockage 30 30
Failure to Power Up 28 28
Excessive Cooling 27 27
Pressure Problem 27 27
Loss of Power 25 25
Output below Specifications 24 24
Component Misassembled 24 24
Physical Resistance/Sticking 24 24
Naturally Worn 22 22
Loss of or Failure to Bond 18 18
Electrical /Electronic Property Problem 18 18
Solder Joint Fracture 18 18
Short Fill 16 16
Disconnection 16 16
Thermal Decomposition of Device 16 16
Product Quality Problem 16 16
Device Emits Odor 15 15
Mechanical Problem 14 14
Unexpected Shutdown 14 14
No Apparent Adverse Event 13 13
Inadequate Instructions for Healthcare Professional 13 13
Unable to Obtain Readings 13 13
Contamination /Decontamination Problem 13 13
Intermittent Loss of Power 12 12
Material Protrusion/Extrusion 11 11
Use of Incorrect Control/Treatment Settings 11 11
Difficult to Remove 10 10
Image Display Error/Artifact 10 10
Inadequate or Insufficient Training 10 10
Loose or Intermittent Connection 8 8
Device Contamination with Chemical or Other Material 8 8
Suction Failure 8 8
Melted 7 7
Communication or Transmission Problem 7 7
Obstruction of Flow 6 6
Expiration Date Error 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9836 9836
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 1130 1130
Alteration In Body Temperature 330 330
Patient Problem/Medical Problem 258 258
Chills 182 182
No Code Available 119 119
Insufficient Information 106 106
Inadequate Pain Relief 101 101
Burn(s) 65 65
Shaking/Tremors 55 55
Convulsion/Seizure 43 43
Partial thickness (Second Degree) Burn 40 40
Death 34 34
Skin Discoloration 34 34
No Information 32 32
Hypothermia 25 25
Blister 23 23
Skin Tears 23 23
Pressure Sores 20 20
Seizures 17 17
Therapeutic Effects, Unexpected 17 17
Erythema 17 17
Full thickness (Third Degree) Burn 16 16
Alteration in Body Temperature 16 16
Superficial (First Degree) Burn 15 15
Burn, Thermal 15 15
Bradycardia 15 15
Unspecified Infection 15 15
Discomfort 15 15
Paralysis 14 14
Fever 14 14
Skin Inflammation/ Irritation 13 13
Low Blood Pressure/ Hypotension 11 11
Rash 11 11
Sepsis 10 10
Skin Irritation 9 9
Necrosis 7 7
Cardiac Arrest 7 7
Swelling 6 6
Tissue Damage 5 5
Burning Sensation 5 5
Pain 5 5
Sedation 5 5
Electric Shock 4 4
Respiratory Failure 4 4
Unspecified Tissue Injury 4 4
Bacterial Infection 4 4
Respiratory Distress 4 4
Brain Injury 3 3
Injury 3 3
Abrasion 3 3
Bruise/Contusion 3 3
Emotional Changes 3 3
High Blood Pressure/ Hypertension 3 3
Hyperthermia 2 2
Hemorrhage/Bleeding 2 2
Cardiopulmonary Arrest 2 2
Exposure to Body Fluids 2 2
Myocardial Infarction 2 2
Peeling 2 2
Pneumonia 2 2
Complaint, Ill-Defined 2 2
Cardiogenic Shock 2 2
Scar Tissue 2 2
Local Reaction 2 2
Tachycardia 2 2
Urinary Tract Infection 2 2
Localized Skin Lesion 2 2
Skin Infection 2 2
Skin Inflammation 2 2
Meningitis 2 2
Chemical Exposure 2 2
Tissue Breakdown 2 2
Not Applicable 2 2
Fluid Discharge 1 1
Multiple Organ Failure 1 1
Low White Blood Cell Count 1 1
Unspecified Heart Problem 1 1
Unspecified Respiratory Problem 1 1
Vascular System (Circulation), Impaired 1 1
Blood Loss 1 1
Underdose 1 1
Confusion/ Disorientation 1 1
Numbness 1 1
Forced Expiratory Volume Increased 1 1
Sweating 1 1
Low Cardiac Output 1 1
Contact Dermatitis 1 1
Swelling/ Edema 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Septic Shock 1 1
Thrombosis 1 1
Respiratory Distress Syndrome of Newborns 1 1
Seizures, Grand-Mal 1 1
Twitching 1 1
Therapeutic Response, Decreased 1 1

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 Mar-26-2024
7 Pintler Medical LLC II Apr-12-2019
8 Tec Com Gmbh II Nov-12-2019
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