TPLC - Total Product Life Cycle

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Device	system, hypothermia, intravenous, cooling
Regulation Description	Thermal regulating system.
Product Code	NCX
Regulation Number	870.5900
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Visual Prompts will not Clear	874	874
Fluid/Blood Leak	544	544
Material Integrity Problem	541	541
Use of Device Problem	267	267
Adverse Event Without Identified Device or Use Problem	56	56
Unexpected Shutdown	39	39
Temperature Problem	35	35
Insufficient Cooling	33	33
Difficult to Remove	26	26
Difficult to Advance	25	25
Failure to Power Up	22	22
Insufficient Heating	21	21
Noise, Audible	18	18
No Display/Image	15	15
Difficult to Insert	11	11
Leak/Splash	9	9
Power Problem	9	9
Unraveled Material	6	6
Material Rupture	6	7
Display or Visual Feedback Problem	6	6
Intermittent Loss of Power	6	6
Complete Loss of Power	6	6
Mechanical Problem	6	6
Infusion or Flow Problem	4	4
Difficult to Flush	4	4
Detachment of Device or Device Component	4	4
Improper Flow or Infusion	3	3
Loss of Power	3	3
Material Split, Cut or Torn	3	3
Display Difficult to Read	3	3
Positioning Problem	2	2
Loose or Intermittent Connection	2	2
Output Problem	2	2
Gas/Air Leak	2	2
Crack	2	2
Break	2	2
Backflow	2	3
Air/Gas in Device	2	2
Pumping Problem	1	1
Excessive Heating	1	1
Incomplete or Inadequate Connection	1	1
Material Twisted/Bent	1	1
Failure to Deflate	1	1
Obstruction of Flow	1	1
Tear, Rip or Hole in Device Packaging	1	1
Defective Component	1	1
No Audible Prompt/Feedback	1	1
Material Separation	1	1
Excessive Cooling	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1366	1366
Insufficient Information	525	526
Thrombosis/Thrombus	35	35
Cardiac Arrest	15	15
Swelling/ Edema	13	13
Hemorrhage/Bleeding	10	10
Pulmonary Embolism	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Infiltration into Tissue	5	5
Hematoma	4	4
Pneumothorax	3	3
Abdominal Pain	2	2
Failure of Implant	2	2
Obstruction/Occlusion	2	2
Cardiac Tamponade	2	2
Unspecified Blood or Lymphatic problem	2	2
Fever	2	2
Air Embolism	1	1
Stroke/CVA	1	1
Brain Injury	1	1
Sepsis	1	1
Inflammation	1	1
Blister	1	1
Pericardial Effusion	1	1
Skin Discoloration	1	1
Foreign Body In Patient	1	1
Hypothermia	1	1
Pain	1	1
Ecchymosis	1	1
Bradycardia	1	1
Shock	1	1
Perforation of Vessels	1	1
Convulsion/Seizure	1	1
Myocardial Infarction	1	1
Heart Block	1	1
Hemothorax	1	1

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