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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
NOVOCOR MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
SEIRATHERM GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZOLL CIRCULATION
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
ZOLL CIRCULATION, INC
  SE - WITH LIMITATIONS 1
ZOLL CIRCULATION, INC.
  SE - WITH LIMITATIONS 4

MDR Year MDR Reports MDR Events
2014 41 41
2015 32 32
2016 310 310
2017 450 450
2018 509 509
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 1317 1317
Fluid/Blood Leak 575 575
Material Integrity Problem 543 543
Device Operates Differently Than Expected 505 505
Device Displays Incorrect Message 408 408
Use of Device Problem 391 391
Leak/Splash 239 239
Adverse Event Without Identified Device or Use Problem 159 159
Device Issue 139 139
Insufficient Cooling 65 65
Temperature Problem 63 63
Failure to Power Up 56 56
Device Operational Issue 52 52
Unexpected Shutdown 44 44
No Display/Image 34 34
Insufficient Heating 33 33
Difficult to Remove 29 29
Difficult to Advance 22 22
Noise, Audible 19 19
Power Problem 18 18
Intermittent Loss of Power 13 13
Mechanical Problem 11 11
Difficult to Insert 10 10
Display or Visual Feedback Problem 10 10
Unraveled Material 10 10
Device Alarm System 8 8
Break 7 7
Loss of Power 7 7
Complete Loss of Power 7 7
Insufficient Information 6 6
Infusion or Flow Problem 6 6
Device Inoperable 6 6
Detachment of Device or Device Component 6 6
Backflow 6 6
Difficult to Flush 6 6
Hole In Material 5 5
Material Rupture 5 5
Defective Component 5 5
Improper Flow or Infusion 5 5
Output Problem 4 4
Material Split, Cut or Torn 4 4
Device Contamination with Body Fluid 4 4
Improper or Incorrect Procedure or Method 4 4
Device Stops Intermittently 4 4
Excessive Cooling 4 4
Display Difficult to Read 4 4
Air Leak 4 4
Crack 3 3
Kinked 3 3
Loose or Intermittent Connection 3 3
Gas/Air Leak 3 3
Retraction Problem 3 3
Appropriate Term/Code Not Available 3 3
Positioning Problem 3 3
Material Twisted/Bent 2 2
Therapeutic or Diagnostic Output Failure 2 2
Air/Gas in Device 2 2
Material Puncture/Hole 2 2
Material Separation 2 2
No Audible Prompt/Feedback 2 2
Defective Device 2 2
Connection Problem 2 2
Excess Flow or Over-Infusion 2 2
Disconnection 2 2
Electrical /Electronic Property Problem 2 2
Entrapment of Device 1 1
Filling Problem 1 1
Inaccurate Flow Rate 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Unintended Power Up 1 1
No Audible Alarm 1 1
Bent 1 1
Burst Container or Vessel 1 1
Collapse 1 1
Detachment Of Device Component 1 1
Failure to Prime 1 1
Off-Label Use 1 1
Occlusion Within Device 1 1
Overheating of Device 1 1
Power Conditioning Problem 1 1
Activation, Positioning or Separation Problem 1 1
Sparking 1 1
Malposition of Device 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Advance 1 1
Device Contamination with Chemical or Other Material 1 1
Electrical Power Problem 1 1
Electrical Shorting 1 1
Insufficient Flow or Under Infusion 1 1
Failure to Deliver 1 1
Inaccurate Delivery 1 1
Component Missing 1 1
Excessive Heating 1 1
Incomplete or Inadequate Connection 1 1
Failure to Deflate 1 1
Unintended Movement 1 1
Pressure Problem 1 1
Protective Measures Problem 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1054 1054
No Known Impact Or Consequence To Patient 890 890
No Consequences Or Impact To Patient 647 647
Insufficient Information 429 429
No Patient Involvement 362 362
Thrombosis 46 46
Thrombosis/Thrombus 28 28
Thrombus 24 24
Cardiac Arrest 21 21
Death 17 17
No Information 17 17
Injury 15 15
Pulmonary Embolism 13 13
Hematoma 10 10
Hemorrhage/Bleeding 10 10
Swelling/ Edema 9 9
Fever 7 7
Pneumonia 7 7
Hypothermia 6 6
No Code Available 6 6
Patient Problem/Medical Problem 5 5
Pneumothorax 5 5
Bacterial Infection 5 5
Edema 4 4
Infiltration into Tissue 4 4
Swelling 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Test Result 3 3
Ventricular Fibrillation 3 3
Pain 3 3
Hemorrhage, Cerebral 3 3
Vessel Or Plaque, Device Embedded In 3 3
Low Blood Pressure/ Hypotension 2 2
Hemorrhage, Subarachnoid 2 2
Hemothorax 2 2
Bradycardia 2 2
Abdominal Pain 2 2
Respiratory Distress 2 2
Seizures 2 2
Shock 2 2
Skin Discoloration 2 2
Unspecified Infection 2 2
Complaint, Ill-Defined 2 2
Brain Injury 2 2
Cardiac Tamponade 2 2
Not Applicable 2 2
Alteration In Body Temperature 2 2
Missing Value Reason 2 2
Chemical Exposure 2 2
Loss of consciousness 2 2
Obstruction/Occlusion 2 2
Respiratory Failure 2 2
Unspecified Blood or Lymphatic problem 2 2
Heart Block 1 1
Blister 1 1
Sudden Cardiac Death 1 1
Cardiac Perforation 1 1
Respiratory Acidosis 1 1
Blood Loss 1 1
Thromboembolism 1 1
Multiple Organ Failure 1 1
Convulsion/Seizure 1 1
Foreign Body In Patient 1 1
Hypernatremia 1 1
Cardiogenic Shock 1 1
Fracture, Arm 1 1
Coma 1 1
Ventricular Tachycardia 1 1
Perforation of Vessels 1 1
Weakness 1 1
Chills 1 1
Body temperature, elevated 1 1
Urinary Tract Infection 1 1
Skull Fracture 1 1
Sepsis 1 1
Staphylococcus Aureus 1 1
Renal Failure 1 1
Phlebitis 1 1
Failure of Implant 1 1
Inflammation 1 1
Ischemia 1 1
Laceration(s) 1 1
Myocardial Infarction 1 1
Neuropathy 1 1
Abrasion 1 1
Air Embolism 1 1
Anemia 1 1
Anoxia 1 1
Arrhythmia 1 1
Atrial Fibrillation 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Ecchymosis 1 1
Stroke/CVA 1 1
Contusion 1 1
Crushing Injury 1 1
Hyperglycemia 1 1
High Blood Pressure/ Hypertension 1 1
Head Injury 1 1
Intracranial Hemorrhage 1 1
Embolus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Philips Healthcare II Jan-27-2014
2 ZOLL Circulation, Inc. II Oct-06-2021
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