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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, hypothermia, intravenous, cooling
Regulation Description Thermal regulating system.
Product CodeNCX
Regulation Number 870.5900
Device Class 2


Premarket Reviews
ManufacturerDecision
ZOLL CIRCULATION, INC
  SE - WITH LIMITATIONS 1
ZOLL CIRCULATION, INC.
  SE - WITH LIMITATIONS 2

MDR Year MDR Reports MDR Events
2020 415 415
2021 461 461
2022 511 511
2023 373 373
2024 343 343
2025 119 119

Device Problems MDRs with this Device Problem Events in those MDRs
Visual Prompts will not Clear 994 994
Fluid/Blood Leak 596 596
Material Integrity Problem 592 592
Use of Device Problem 288 288
Adverse Event Without Identified Device or Use Problem 57 57
Unexpected Shutdown 42 42
Temperature Problem 42 42
Insufficient Cooling 40 40
Failure to Power Up 35 35
Insufficient Heating 27 27
Difficult to Advance 27 27
Difficult to Remove 25 25
Noise, Audible 21 21
No Display/Image 18 18
Power Problem 11 11
Difficult to Insert 10 10
Mechanical Problem 9 9
Leak/Splash 8 8
Intermittent Loss of Power 8 8
Unraveled Material 8 8
Display or Visual Feedback Problem 7 7
Complete Loss of Power 6 6
Material Rupture 6 6
Difficult to Flush 5 5
Infusion or Flow Problem 5 5
Break 4 4
Detachment of Device or Device Component 4 4
Material Split, Cut or Torn 3 3
Display Difficult to Read 3 3
Retraction Problem 3 3
Loss of Power 2 2
Material Twisted/Bent 2 2
Improper Flow or Infusion 2 2
Gas/Air Leak 2 2
Backflow 2 2
Air/Gas in Device 2 2
Positioning Problem 2 2
Crack 2 2
Output Problem 2 2
Excessive Cooling 2 2
No Audible Alarm 1 1
Therapeutic or Diagnostic Output Failure 1 1
Inaccurate Flow Rate 1 1
Defective Device 1 1
No Audible Prompt/Feedback 1 1
Defective Component 1 1
Material Puncture/Hole 1 1
Material Separation 1 1
Tear, Rip or Hole in Device Packaging 1 1
Electrical Shorting 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1332 1332
Insufficient Information 516 516
No Consequences Or Impact To Patient 205 205
No Patient Involvement 63 63
Thrombosis/Thrombus 34 34
Cardiac Arrest 15 15
Hemorrhage/Bleeding 11 11
Swelling/ Edema 11 11
Pulmonary Embolism 9 9
Infiltration into Tissue 5 5
Pneumothorax 5 5
Hematoma 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Injury 3 3
No Known Impact Or Consequence To Patient 3 3
Cardiac Tamponade 2 2
Obstruction/Occlusion 2 2
Unspecified Blood or Lymphatic problem 2 2
Fever 2 2
Failure of Implant 2 2
Death 2 2
Hemothorax 2 2
Abdominal Pain 2 2
Pericardial Effusion 1 1
Blister 1 1
Abrasion 1 1
Skin Discoloration 1 1
Inflammation 1 1
Brain Injury 1 1
Ventricular Fibrillation 1 1
Foreign Body In Patient 1 1
Sepsis 1 1
Ecchymosis 1 1
Hypothermia 1 1
Pain 1 1
Bradycardia 1 1
Stroke/CVA 1 1
Shock 1 1
Perforation of Vessels 1 1
Sudden Cardiac Death 1 1
Myocardial Infarction 1 1
Convulsion/Seizure 1 1
Air Embolism 1 1
Vessel Or Plaque, Device Embedded In 1 1
Loss of consciousness 1 1
Heart Block 1 1
Thrombus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 ZOLL Circulation, Inc. II Oct-06-2021
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