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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
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 1
SMITHS MEDICAL ASD, INC.
  SUBSTANTIALLY EQUIVALENT 1
STERIS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STIHLER ELECTRONIC GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 1517 1517
2019 2294 2294
2020 2546 2546
2021 2693 2693
2022 3237 3237

Device Problems MDRs with this Device Problem Events in those MDRs
Defective Component 2278 2278
Insufficient Cooling 1818 1818
Device Sensing Problem 1600 1600
Temperature Problem 1328 1328
Inaccurate Flow Rate 1087 1087
Insufficient Heating 930 930
Failure to Pump 911 911
Device Displays Incorrect Message 777 777
Gas/Air Leak 774 774
Restricted Flow rate 705 705
Circuit Failure 495 495
Decreased Pump Speed 434 434
Pumping Problem 384 384
Failure to Calibrate 337 337
Overheating of Device 229 229
Adverse Event Without Identified Device or Use Problem 229 229
Computer Operating System Problem 229 229
Operating System Becomes Nonfunctional 226 226
Device Alarm System 218 218
Nonstandard Device 206 206
No Flow 201 201
Display or Visual Feedback Problem 187 187
Infusion or Flow Problem 185 185
Therapeutic or Diagnostic Output Failure 184 184
Fluid/Blood Leak 163 163
Device Operates Differently Than Expected 141 141
Defective Device 140 140
Protective Measures Problem 134 134
Improper or Incorrect Procedure or Method 129 129
Insufficient Flow or Under Infusion 120 120
Filling Problem 110 110
Use of Device Problem 106 106
Patient-Device Incompatibility 98 98
Break 92 92
Material Fragmentation 91 91
Leak/Splash 88 88
Insufficient Information 86 86
No Display/Image 85 85
Biocompatibility 80 80
Incorrect, Inadequate or Imprecise Result or Readings 79 79
Power Problem 75 75
Computer Software Problem 74 74
Appropriate Term/Code Not Available 70 70
Component Missing 61 61
Overfill 60 60
Fitting Problem 54 54
Output Problem 52 52
Material Split, Cut or Torn 51 51
Noise, Audible 50 50
Improper Flow or Infusion 49 49
Deformation Due to Compressive Stress 47 47
Electrical Shorting 47 47
Calibration Problem 45 45
Misassembly by Users 43 43
Loss of Power 38 38
Material Separation 34 34
Material Twisted/Bent 34 34
Patient Device Interaction Problem 34 34
Device Dislodged or Dislocated 32 32
Erratic or Intermittent Display 32 32
Failure to Sense 31 31
Pressure Problem 31 31
Excessive Heating 30 30
Failure to Power Up 28 28
Air Leak 27 27
Device Handling Problem 26 26
Output below Specifications 26 26
Fracture 25 25
Device Emits Odor 23 23
Excessive Cooling 23 23
Alarm Not Visible 22 22
Device Inoperable 21 21
Loss of or Failure to Bond 19 19
Electrical /Electronic Property Problem 19 19
Unable to Obtain Readings 18 18
Physical Resistance/Sticking 18 18
Thermal Decomposition of Device 17 17
Component Misassembled 16 16
Failure of Device to Self-Test 16 16
Contamination /Decontamination Problem 16 16
Short Fill 15 15
Suction Problem 15 15
Solder Joint Fracture 14 14
Loose or Intermittent Connection 14 14
Unexpected Shutdown 14 14
Naturally Worn 13 13
Mechanical Problem 13 13
Partial Blockage 13 13
No Apparent Adverse Event 12 12
Intermittent Loss of Power 12 12
Crack 11 11
Image Display Error/Artifact 11 11
Inadequate or Insufficient Training 10 10
Device Contamination with Chemical or Other Material 10 10
Suction Failure 9 9
Inadequacy of Device Shape and/or Size 9 9
Difficult to Remove 9 9
Product Quality Problem 9 9
Inadequate Instructions for Healthcare Professional 9 9
Melted 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5981 5981
No Known Impact Or Consequence To Patient 3684 3684
No Consequences Or Impact To Patient 3305 3305
No Patient Involvement 1961 1961
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 653 653
Alteration In Body Temperature 627 627
Patient Problem/Medical Problem 358 358
No Code Available 148 148
Chills 131 131
No Information 108 108
Inadequate Pain Relief 106 106
Insufficient Information 94 94
Shaking/Tremors 72 72
Burn(s) 66 66
Death 48 48
Hypothermia 43 43
Partial thickness (Second Degree) Burn 38 38
Seizures 29 29
Skin Discoloration 29 29
Fever 28 28
Convulsion/Seizure 27 27
Burn, Thermal 25 25
Therapeutic Effects, Unexpected 25 25
Skin Tears 20 20
Pressure Sores 20 20
Blister 19 19
Unspecified Infection 19 19
Erythema 17 17
Bradycardia 17 17
Discomfort 16 16
Injury 15 15
Full thickness (Third Degree) Burn 14 14
Alteration in Body Temperature 14 14
Paralysis 14 14
Rash 13 13
Skin Irritation 13 13
Cardiac Arrest 12 12
Low Blood Pressure/ Hypotension 12 12
Skin Inflammation/ Irritation 11 11
Superficial (First Degree) Burn 11 11
Sepsis 10 10
Pneumonia 10 10
Bacterial Infection 9 9
Necrosis 7 7
Swelling 7 7
Tissue Damage 7 7
Hyperthermia 6 6
Pain 5 5
Sedation 5 5
Respiratory Failure 5 5
Therapeutic Response, Decreased 5 5
Complaint, Ill-Defined 4 4
Pulmonary Edema 4 4
Respiratory Distress 4 4
Twitching 4 4
High Blood Pressure/ Hypertension 4 4
Hypoxia 4 4
Bruise/Contusion 4 4
Cardiopulmonary Arrest 3 3
Abrasion 3 3
Emotional Changes 3 3
Burning Sensation 3 3
Brain Injury 3 3
Skin Inflammation 3 3
Sweating 2 2
Meningitis 2 2
Tissue Breakdown 2 2
Not Applicable 2 2
Confusion/ Disorientation 2 2
Electric Shock 2 2
Chemical Exposure 2 2
Unspecified Tissue Injury 2 2
Cardiogenic Shock 2 2
Urinary Tract Infection 2 2
Local Reaction 2 2
Myocardial Infarction 2 2
Peeling 2 2
Exposure to Body Fluids 2 2
Hemorrhage/Bleeding 2 2
Irritation 2 2
Ischemia 1 1
Itching Sensation 1 1
Laceration(s) 1 1
Overdose 1 1
Inflammation 1 1
Hemorrhage, Cerebral 1 1
Hypersensitivity/Allergic reaction 1 1
Hypovolemic Shock 1 1
Air Embolism 1 1
Atrial Fibrillation 1 1
Encephalopathy 1 1
Edema 1 1
Stacking Breaths 1 1
Hematoma 1 1
Tachycardia 1 1
Septic Shock 1 1
Shock 1 1
Ventricular Fibrillation 1 1
Ventricular Tachycardia 1 1
Respiratory Distress Syndrome of Newborns 1 1

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 Belmont Instrument Corporation II Oct-31-2022
5 C.R. Bard, Inc. III Feb-12-2018
6 Care Essentials Pty., Ltd. II Mar-03-2020
7 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Nov-18-2019
8 Cincinnati Sub-Zero Products LLC, a Gentherm Company II Sep-04-2019
9 Medtronic Perfusion Systems II Mar-06-2018
10 Pintler Medical LLC II Apr-12-2019
11 Stryker Medical Division of Stryker Corporation II Oct-24-2018
12 Stryker Medical Division of Stryker Corporation II Jan-27-2018
13 Tec Com Gmbh II Nov-12-2019
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