Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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
2017 450 450
2018 509 509
2019 438 438
2020 415 415
2021 461 461
2022 511 511
2023 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Visual Prompts will not Clear 1085 1085
Fluid/Blood Leak 457 457
Material Integrity Problem 435 435
Device Operates Differently Than Expected 380 380
Use of Device Problem 323 323
Device Displays Incorrect Message 296 296
Leak/Splash 172 172
Device Issue 129 129
Adverse Event Without Identified Device or Use Problem 99 99
Failure to Power Up 47 47
Insufficient Cooling 45 45
Device Operational Issue 43 43
Temperature Problem 43 43
Unexpected Shutdown 39 39
No Display/Image 28 28
Difficult to Remove 27 27
Insufficient Heating 27 27
Difficult to Advance 18 18
Noise, Audible 16 16
Power Problem 14 14
Mechanical Problem 11 11
Intermittent Loss of Power 11 11
Display or Visual Feedback Problem 10 10
Unraveled Material 9 9
Difficult to Insert 8 8
Break 6 6
Material Rupture 5 5
Device Inoperable 5 5
Detachment of Device or Device Component 5 5
Complete Loss of Power 5 5
Material Split, Cut or Torn 4 4
Infusion or Flow Problem 4 4
Output Problem 4 4
Defective Component 4 4
Difficult to Flush 4 4
Device Alarm System 4 4
Backflow 4 4
Loose or Intermittent Connection 3 3
Retraction Problem 3 3
Display Difficult to Read 3 3
Excessive Cooling 3 3
Gas/Air Leak 3 3
Improper Flow or Infusion 3 3
Appropriate Term/Code Not Available 3 3
Material Twisted/Bent 2 2
Positioning Problem 2 2
Device Contamination with Body Fluid 2 2
No Audible Prompt/Feedback 2 2
Material Puncture/Hole 2 2
Improper or Incorrect Procedure or Method 2 2
Defective Device 2 2
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Sparking 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1
Insufficient Flow or Under Infusion 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Material Protrusion/Extrusion 1 1
Device Contamination with Chemical or Other Material 1 1
Electrical Shorting 1 1
Off-Label Use 1 1
Device Stops Intermittently 1 1
Kinked 1 1
Excess Flow or Over-Infusion 1 1
Air Leak 1 1
No Audible Alarm 1 1
Burst Container or Vessel 1 1
Collapse 1 1
Detachment Of Device Component 1 1
Electrical /Electronic Property Problem 1 1
Inaccurate Flow Rate 1 1
Crack 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Unintended Power Up 1 1
Therapeutic or Diagnostic Output Failure 1 1
Physical Resistance/Sticking 1 1
Excessive Heating 1 1
Incomplete or Inadequate Connection 1 1
Air/Gas in Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 781 781
No Known Impact Or Consequence To Patient 740 740
No Consequences Or Impact To Patient 531 531
No Patient Involvement 323 323
Insufficient Information 321 321
Thrombosis 29 29
Thrombosis/Thrombus 18 18
Injury 13 13
Pulmonary Embolism 10 10
Cardiac Arrest 9 9
Death 9 9
Hemorrhage/Bleeding 8 8
Thrombus 7 7
No Information 7 7
Swelling/ Edema 7 7
Hematoma 6 6
Pneumothorax 5 5
Infiltration into Tissue 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Vessel Or Plaque, Device Embedded In 3 3
Edema 2 2
Fever 2 2
Hemothorax 2 2
Hypothermia 2 2
Bacterial Infection 2 2
Abdominal Pain 2 2
Shock 2 2
Cardiac Tamponade 2 2
Unspecified Blood or Lymphatic problem 2 2
No Code Available 2 2
Unspecified Infection 2 2
Patient Problem/Medical Problem 2 2
Obstruction/Occlusion 2 2
Chemical Exposure 2 2
Blood Loss 1 1
Foreign Body In Patient 1 1
Sudden Cardiac Death 1 1
Cardiac Perforation 1 1
Loss of consciousness 1 1
Heart Block 1 1
Blister 1 1
Missing Value Reason 1 1
Convulsion/Seizure 1 1
Cardiogenic Shock 1 1
Brain Injury 1 1
Ventricular Fibrillation 1 1
Perforation of Vessels 1 1
Skin Discoloration 1 1
Swelling 1 1
Respiratory Distress 1 1
Sepsis 1 1
Inflammation 1 1
Myocardial Infarction 1 1
Pain 1 1
Abrasion 1 1
Atrial Fibrillation 1 1
Bradycardia 1 1
Ecchymosis 1 1
Failure of Implant 1 1
Hemorrhage, Cerebral 1 1

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