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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 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
  1.  K202197  Astopad Patient Warming System
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 2692 2692

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 1965 1965
Temperature Problem 1715 1715
Insufficient Cooling 1581 1581
Device Displays Incorrect Message 1446 1446
Device Sensing Problem 1224 1224
Inaccurate Flow Rate 978 978
Insufficient Heating 767 767
Device Operates Differently Than Expected 518 518
Restricted Flow rate 508 508
Failure to Pump 492 492
Gas Leak 420 420
Circuit Failure 349 349
Microbial Contamination of Device 331 331
Pumping Problem 320 320
Adverse Event Without Identified Device or Use Problem 296 296
No Flow 287 287
Insufficient Flow or Under Infusion 279 279
Decreased Pump Speed 277 277
Infusion or Flow Problem 256 256
Product Quality Problem 236 236
Device Alarm System 222 222
Contamination 195 195
Display or Visual Feedback Problem 190 190
Therapeutic or Diagnostic Output Failure 189 189
Failure to Calibrate 187 187
Computer Operating System Problem 179 179
Fluid Leak 172 172
Leak/Splash 153 153
Overheating of Device 152 152
Improper or Incorrect Procedure or Method 151 151
Filling Problem 144 144
Defective Device 144 144
Protective Measures Problem 134 134
Insufficient Information 133 133
Air Leak 127 127
Operating System Becomes Nonfunctional 116 116
Patient-Device Incompatibility 110 110
Break 107 107
Use of Device Problem 106 106
Improper Flow or Infusion 98 98
No Display/Image 91 91
Incorrect, Inadequate or Imprecise Resultor Readings 85 85
Appropriate Term/Code Not Available 84 84
Biocompatibility 78 78
Loss of Power 63 63
Device Inoperable 62 62
Output Problem 58 58
Noise, Audible 55 55
Calibration Problem 49 49
Nonstandard Device 47 47
Output below Specifications 43 43
Power Problem 43 43
Component Missing 42 42
Contamination /Decontamination Problem 41 41
Computer Software Problem 40 40
Material Fragmentation 38 38
Pressure Problem 37 37
Electrical Shorting 34 34
Failure to Power Up 33 33
Device Emits Odor 32 32
Misassembly by Users 32 32
Fitting Problem 30 30
Material Separation 29 29
Unable to Obtain Readings 28 28
Excessive Cooling 27 27
Overfill 27 27
Device Dislodged or Dislocated 26 26
Material Split, Cut or Torn 25 25
Thermal Decomposition of Device 25 25
Suction Problem 24 24
Failure to Sense 24 24
Erratic or Intermittent Display 23 23
Electrical /Electronic Property Problem 22 22
Material Twisted/Bent 22 22
Deformation Due to Compressive Stress 22 22
Connection Problem 19 19
Excessive Heating 19 19
Failure of Device to Self-Test 18 18
Loose or Intermittent Connection 18 18
Loss of or Failure to Bond 17 17
Unexpected Therapeutic Results 17 17
Improper Device Output 17 17
Device Disinfection Or Sterilization Issue 15 15
Smoking 15 15
Short Fill 13 13
Moisture Damage 13 13
Crack 13 13
Unexpected Shutdown 13 13
No Apparent Adverse Event 13 13
Physical Resistance/Sticking 12 12
Alarm Not Visible 12 12
Device Maintenance Issue 12 12
Melted 12 12
Self-Activation or Keying 11 11
Inadequacy of Device Shape and/or Size 11 11
Naturally Worn 11 11
Intermittent Loss of Power 10 10
Contamination of Device Ingredient or Reagent 10 10
Mechanical Problem 10 10
Failure To Adhere Or Bond 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 3556 3556
No Clinical Signs, Symptoms or Conditions 3035 3035
No Patient Involvement 2022 2022
Alteration In Body Temperature 917 917
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 380 380
Patient Problem/Medical Problem 366 366
Unspecified Infection 355 355
No Information 325 325
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
Insufficient Information 86 86
Shaking/Tremors 82 82
Burn(s) 78 78
Chills 72 72
Therapeutic Effects, Unexpected 67 67
Partial thickness (Second Degree) Burn 64 64
Hypothermia 62 62
Burn, Thermal 43 43
Fever 40 40
Erythema 39 39
Ambulation Difficulties 36 36
Seizures 35 35
Skin Discoloration 34 34
Superficial (First Degree) Burn 31 31
Skin Tears 29 29
Staphylococcus Aureus 28 28
Pain 28 28
Cardiac Arrest 26 26
Tissue Damage 25 25
Swelling 24 24
Skin Irritation 22 22
Bradycardia 20 20
Rash 17 17
Pressure Sores 17 17
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 13 13
Pneumonia 12 12
Paralysis 12 12
Blister 11 11
Convulsion/Seizure 10 10
Hyperthermia 10 10
Necrosis 9 9
Therapeutic Response, Decreased 9 9
Skin Inflammation/ Irritation 9 9
Not Applicable 9 9
Complaint, Ill-Defined 8 8
Brain Injury 7 7
Twitching 7 7
Respiratory Failure 7 7
Burning Sensation 6 6
Cardiopulmonary Arrest 6 6
High Blood Pressure/ Hypertension 5 5
Edema 5 5
Hypoxia 5 5
Pulmonary Edema 5 5
Respiratory Distress 5 5
Sedation 5 5
Skin Inflammation 5 5
Tissue Breakdown 5 5
Disability 4 4
Tachycardia 4 4
Bruise/Contusion 4 4
Abrasion 4 4
Emotional Changes 3 3
Hematoma 3 3
Hemorrhage/Bleeding 3 3
Septic Shock 3 3
Irritation 3 3
Cardiogenic Shock 3 3
Electric Shock 3 3
Sweating 3 3
Multiple Organ Failure 3 3
Underdose 2 2
Meningitis 2 2
Reaction 2 2
Post Traumatic Wound Infection 2 2
Confusion/ Disorientation 2 2
Blood Loss 2 2
Test Result 2 2
Fluid Discharge 2 2
Foreign Body In Patient 2 2
Electrolyte Imbalance 2 2
Urinary Tract Infection 2 2
Ischemia 2 2
Peeling 2 2
Inflammation 2 2
Myocardial Infarction 2 2
Local Reaction 2 2
Renal Failure 2 2
Coagulation Disorder 2 2
Fall 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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