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TPLC
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Device
system, hypothermia, intravenous, cooling
Product Code
NCX
Regulation Number
870.5900
Device Class
2
Premarket Reviews
Manufacturer
Decision
NOVOCOR MEDICAL SYSTEMS, INC
SUBSTANTIALLY EQUIVALENT
1
SEIRATHERM GMBH
SUBSTANTIALLY EQUIVALENT
1
ZOLL CIRCULATION
SE - WITH LIMITATIONS
1
SUBSTANTIALLY EQUIVALENT
1
1. K141139
SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER
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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