TPLC - Total Product Life Cycle

show TPLC since

Device	system, hypothermia, intravenous, cooling
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	1113	1113
Fluid/Blood Leak	606	606
Material Integrity Problem	599	599
Use of Device Problem	317	317
Adverse Event Without Identified Device or Use Problem	67	67
Temperature Problem	47	47
Insufficient Cooling	46	46
Unexpected Shutdown	44	44
Failure to Power Up	44	44
Difficult to Remove	27	27
Insufficient Heating	25	25
Difficult to Advance	23	23
Noise, Audible	20	20
No Display/Image	18	18
Power Problem	18	18
Intermittent Loss of Power	13	13
Mechanical Problem	12	12
Unraveled Material	10	10
Leak/Splash	8	8
Detachment of Device or Device Component	7	7
Display or Visual Feedback Problem	7	7
Complete Loss of Power	7	7
Difficult to Insert	7	7
Infusion or Flow Problem	5	5
Material Rupture	5	5
Difficult to Flush	5	5
Display Difficult to Read	5	5
Backflow	4	4
Break	4	4
Material Split, Cut or Torn	4	4
Gas/Air Leak	3	3
Output Problem	3	3
Retraction Problem	3	3
Positioning Problem	2	2
Defective Component	2	2
Improper Flow or Infusion	2	2
Material Twisted/Bent	2	2
Material Puncture/Hole	2	2
No Audible Prompt/Feedback	2	2
Crack	2	2
Appropriate Term/Code Not Available	2	2
Air/Gas in Device	2	2
Excessive Cooling	2	2
Failure to Advance	1	1
Connection Problem	1	1
Failure to Deflate	1	1
Excessive Heating	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	1164	1164
Insufficient Information	460	460
No Consequences Or Impact To Patient	451	451
No Patient Involvement	163	163
No Known Impact Or Consequence To Patient	75	75
Thrombosis/Thrombus	32	32
Cardiac Arrest	15	15
Hemorrhage/Bleeding	11	11
Pulmonary Embolism	9	9
Swelling/ Edema	9	9
Injury	9	9
Thrombus	6	6
Pneumothorax	5	5
Hematoma	5	5
Infiltration into Tissue	4	4
Thrombosis	4	4
Death	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Vessel Or Plaque, Device Embedded In	3	3
Cardiac Tamponade	2	2
Obstruction/Occlusion	2	2
Unspecified Blood or Lymphatic problem	2	2
Fever	2	2
Hemothorax	2	2
Abdominal Pain	2	2
Chemical Exposure	1	1
Blood Loss	1	1
Blister	1	1
Abrasion	1	1
Skin Discoloration	1	1
Inflammation	1	1
No Code Available	1	1
Ventricular Fibrillation	1	1
Foreign Body In Patient	1	1
Brain Injury	1	1
Sepsis	1	1
Failure of Implant	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
Loss of consciousness	1	1
Heart Block	1	1

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