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TPLC
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Device
system, hypothermia, intravenous, cooling
Regulation Description
Thermal regulating system.
Product Code
NCX
Regulation Number
870.5900
Device Class
2
Premarket Reviews
Manufacturer
Decision
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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