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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 3
AUGUSTINE TEMPERATURE MANAGEMENT
  SUBSTANTIALLY EQUIVALENT 1
BCG MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BRAIN COOL AB
  SUBSTANTIALLY EQUIVALENT 1
CARE ESSENTIALS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
ENCOMPASS GROUP, LLC
  SUBSTANTIALLY EQUIVALENT 1
IOB MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 2
MEDIVANCE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
THE SURGICAL COMPANY INTERNATIONAL BV (AS THE 37COMPANY)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2016 1400 1400
2017 1472 1472
2018 1516 1516
2019 2294 2294
2020 2546 2546
2021 1978 1978

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 1838 1838
Temperature Problem 1712 1712
Insufficient Cooling 1456 1456
Device Displays Incorrect Message 1445 1445
Device Sensing Problem 1126 1126
Inaccurate Flow Rate 929 929
Insufficient Heating 696 696
Device Operates Differently Than Expected 518 518
Restricted Flow rate 474 474
Failure to Pump 383 383
Gas Leak 349 349
Microbial Contamination of Device 331 331
Circuit Failure 302 302
Adverse Event Without Identified Device or Use Problem 294 294
No Flow 287 287
Insufficient Flow or Under Infusion 279 279
Pumping Problem 270 270
Infusion or Flow Problem 256 256
Product Quality Problem 235 235
Device Alarm System 219 219
Decreased Pump Speed 206 206
Contamination 195 195
Display or Visual Feedback Problem 190 190
Therapeutic or Diagnostic Output Failure 188 188
Computer Operating System Problem 169 169
Failure to Calibrate 165 165
Fluid Leak 165 165
Leak/Splash 153 153
Overheating of Device 147 147
Improper or Incorrect Procedure or Method 146 146
Filling Problem 144 144
Defective Device 144 144
Protective Measures Problem 134 134
Insufficient Information 129 129
Air Leak 127 127
Patient-Device Incompatibility 110 110
Break 107 107
Use of Device Problem 100 100
Improper Flow or Infusion 98 98
No Display/Image 91 91
Operating System Becomes Nonfunctional 89 89
Incorrect, Inadequate or Imprecise Resultor Readings 85 85
Appropriate Term/Code Not Available 84 84
Biocompatibility 76 76
Loss of Power 63 63
Device Inoperable 62 62
Output Problem 57 57
Noise, Audible 54 54
Calibration Problem 49 49
Output below Specifications 43 43
Contamination /Decontamination Problem 41 41
Nonstandard Device 38 38
Pressure Problem 37 37
Computer Software Problem 37 37
Power Problem 35 35
Material Fragmentation 33 33
Failure to Power Up 33 33
Component Missing 32 32
Device Emits Odor 32 32
Electrical Shorting 30 30
Fitting Problem 28 28
Unable to Obtain Readings 28 28
Excessive Cooling 26 26
Material Separation 25 25
Thermal Decomposition of Device 25 25
Suction Problem 24 24
Device Dislodged or Dislocated 24 24
Material Split, Cut or Torn 22 22
Electrical /Electronic Property Problem 22 22
Misassembly by Users 21 21
Material Twisted/Bent 21 21
Overfill 21 21
Failure to Sense 20 20
Erratic or Intermittent Display 20 20
Connection Problem 19 19
Failure of Device to Self-Test 18 18
Excessive Heating 18 18
Loose or Intermittent Connection 18 18
Unexpected Therapeutic Results 17 17
Improper Device Output 17 17
Loss of or Failure to Bond 16 16
Smoking 15 15
Device Disinfection Or Sterilization Issue 15 15
Short Fill 13 13
Moisture Damage 13 13
Crack 13 13
Deformation Due to Compressive Stress 13 13
No Apparent Adverse Event 13 13
Unexpected Shutdown 12 12
Device Maintenance Issue 12 12
Physical Resistance/Sticking 12 12
Self-Activation or Keying 11 11
Inadequacy of Device Shape and/or Size 11 11
Melted 11 11
Device Reprocessing Problem 10 10
Mechanical Problem 10 10
Naturally Worn 10 10
Alarm Not Visible 10 10
Failure To Adhere Or Bond 10 10
Contamination of Device Ingredient or Reagent 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 4853 4853
No Consequences Or Impact To Patient 3558 3558
No Clinical Signs, Symptoms or Conditions 2366 2366
No Patient Involvement 2022 2022
Alteration In Body Temperature 917 917
Patient Problem/Medical Problem 366 366
Unspecified Infection 352 352
No Information 325 325
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 288 288
No Code Available 212 212
Post Operative Wound Infection 166 166
Death 121 121
Inadequate Pain Relief 118 118
Injury 108 108
Bacterial Infection 98 98
Shaking/Tremors 82 82
Insufficient Information 80 80
Burn(s) 77 77
Therapeutic Effects, Unexpected 67 67
Partial thickness (Second Degree) Burn 64 64
Hypothermia 62 62
Chills 52 52
Burn, Thermal 43 43
Fever 40 40
Erythema 38 38
Ambulation Difficulties 36 36
Seizures 35 35
Skin Discoloration 34 34
Staphylococcus Aureus 28 28
Superficial (First Degree) Burn 28 28
Skin Tears 28 28
Pain 27 27
Cardiac Arrest 26 26
Tissue Damage 25 25
Swelling 24 24
Skin Irritation 22 22
Pressure Sores 16 16
Rash 16 16
Bradycardia 16 16
Limited Mobility Of The Implanted Joint 15 15
Sepsis 15 15
Low Blood Pressure/ Hypotension 14 14
Discomfort 14 14
Full thickness (Third Degree) Burn 14 14
Alteration in Body Temperature 12 12
Blister 11 11
Pneumonia 11 11
Paralysis 10 10
Hyperthermia 10 10
Necrosis 9 9
Therapeutic Response, Decreased 9 9
Not Applicable 9 9
Skin Inflammation/ Irritation 8 8
Complaint, Ill-Defined 8 8
Twitching 7 7
Brain Injury 7 7
Respiratory Failure 7 7
Cardiopulmonary Arrest 6 6
Burning Sensation 6 6
Tissue Breakdown 5 5
Pulmonary Edema 5 5
Respiratory Distress 5 5
Hypoxia 5 5
Edema 5 5
High Blood Pressure/ Hypertension 5 5
Convulsion/Seizure 5 5
Sedation 5 5
Skin Inflammation 5 5
Abrasion 4 4
Bruise/Contusion 4 4
Tachycardia 4 4
Disability 4 4
Electric Shock 3 3
Cardiogenic Shock 3 3
Hemorrhage/Bleeding 3 3
Emotional Changes 3 3
Hematoma 3 3
Irritation 3 3
Sweating 3 3
Septic Shock 3 3
Multiple Organ Failure 3 3
Underdose 2 2
Fluid Discharge 2 2
Ischemia 2 2
Peeling 2 2
Renal Failure 2 2
Inflammation 2 2
Fall 2 2
Air Embolism 2 2
Anemia 2 2
Coagulation Disorder 2 2
Head Injury 2 2
Exposure to Body Fluids 2 2
Local Reaction 2 2
Myocardial Infarction 2 2
Electrolyte Imbalance 2 2
Urinary Tract Infection 2 2
Confusion/ Disorientation 2 2
Blood Loss 2 2
Post Traumatic Wound Infection 2 2

Recalls
Manufacturer Recall Class Date Posted
1 3M Company - Health Care Business II Feb-12-2018
2 Bard Medical Division II Apr-27-2019
3 Bard Medical Division II Jul-24-2018
4 C.R. Bard, Inc. III Feb-12-2018
5 C.R. Bard, Inc. II Dec-20-2017
6 C.R. Bard, Inc. II Aug-16-2017
7 C.R. Bard, Inc. III Aug-05-2016
8 C.R. Bard, Inc. II May-06-2016
9 C.R. Bard, Inc. II Apr-14-2016
10 C.R. Bard, Inc. II Feb-05-2016
11 Care Essentials Pty., Ltd. II Mar-03-2020
12 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Nov-18-2019
13 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Sep-04-2019
14 Medtronic Perfusion Systems II Mar-06-2018
15 Pintler Medical LLC II Apr-12-2019
16 Stryker Medical Division of Stryker Corporation II Oct-24-2018
17 Stryker Medical Division of Stryker Corporation II Jan-27-2018
18 Stryker Medical Division of Stryker Corporation II May-10-2017
19 Tec Com Gmbh II Nov-12-2019
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