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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
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
2019 438 438
2020 415 415
2021 461 461
2022 511 511
2023 373 373
2024 84 84

Device Problems MDRs with this Device Problem Events in those MDRs
Visual Prompts will not Clear 1055 1055
Fluid/Blood Leak 551 551
Material Integrity Problem 543 543
Use of Device Problem 304 304
Adverse Event Without Identified Device or Use Problem 63 63
Temperature Problem 47 47
Unexpected Shutdown 44 44
Insufficient Cooling 43 43
Failure to Power Up 41 41
Difficult to Remove 25 25
Insufficient Heating 25 25
Difficult to Advance 22 22
Noise, Audible 19 19
No Display/Image 18 18
Power Problem 17 17
Intermittent Loss of Power 13 13
Mechanical Problem 11 11
Unraveled Material 10 10
Leak/Splash 8 8
Display or Visual Feedback Problem 7 7
Complete Loss of Power 7 7
Detachment of Device or Device Component 6 6
Infusion or Flow Problem 5 5
Difficult to Insert 5 5
Difficult to Flush 5 5
Material Rupture 5 5
Display Difficult to Read 4 4
Backflow 4 4
Break 4 4
Material Split, Cut or Torn 4 4
Output Problem 3 3
Gas/Air Leak 3 3
Retraction Problem 3 3
Material Puncture/Hole 2 2
No Audible Prompt/Feedback 2 2
Defective Component 2 2
Crack 2 2
Improper Flow or Infusion 2 2
Excessive Cooling 2 2
Positioning Problem 2 2
Material Twisted/Bent 2 2
Appropriate Term/Code Not Available 2 2
Air/Gas in Device 2 2
Physical Resistance/Sticking 1 1
Excessive Heating 1 1
Incomplete or Inadequate Connection 1 1
Failure to Deflate 1 1
Material Protrusion/Extrusion 1 1
Therapeutic or Diagnostic Output Failure 1 1
Electrical Shorting 1 1
Unintended Power Up 1 1
Collapse 1 1
Device Alarm System 1 1
No Audible Alarm 1 1
Electrical /Electronic Property Problem 1 1
Inaccurate Flow Rate 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Sparking 1 1
Malposition of Device 1 1
Connection Problem 1 1
Loss of Power 1 1
Material Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1054 1054
No Consequences Or Impact To Patient 451 451
Insufficient Information 429 429
No Patient Involvement 163 163
No Known Impact Or Consequence To Patient 75 75
Thrombosis/Thrombus 28 28
Cardiac Arrest 13 13
Pulmonary Embolism 9 9
Hemorrhage/Bleeding 9 9
Injury 9 9
Swelling/ Edema 9 9
Thrombus 6 6
Hematoma 5 5
Pneumothorax 5 5
Thrombosis 4 4
Infiltration into Tissue 4 4
Death 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Vessel Or Plaque, Device Embedded In 3 3
Fever 2 2
Abdominal Pain 2 2
Hemothorax 2 2
Obstruction/Occlusion 2 2
Cardiac Tamponade 2 2
Unspecified Blood or Lymphatic problem 2 2
Heart Block 1 1
Blister 1 1
No Code Available 1 1
Convulsion/Seizure 1 1
Foreign Body In Patient 1 1
Sudden Cardiac Death 1 1
Chemical Exposure 1 1
Blood Loss 1 1
Loss of consciousness 1 1
Brain Injury 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1
Sepsis 1 1
Shock 1 1
Skin Discoloration 1 1
Hypothermia 1 1
Failure of Implant 1 1
Inflammation 1 1
Myocardial Infarction 1 1
Pain 1 1
Abrasion 1 1
Air Embolism 1 1
Bradycardia 1 1
Ecchymosis 1 1

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