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	942	942
Fluid/Blood Leak	556	556
Material Integrity Problem	551	551
Use of Device Problem	271	271
Adverse Event Without Identified Device or Use Problem	57	57
Temperature Problem	42	42
Unexpected Shutdown	40	40
Insufficient Cooling	40	40
Failure to Power Up	33	33
Difficult to Advance	26	26
Difficult to Remove	25	25
Insufficient Heating	24	24
Noise, Audible	20	20
No Display/Image	15	15
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	6	6
Complete Loss of Power	6	6
Difficult to Flush	5	5
Material Rupture	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
Defective Device	1	1
Inaccurate Flow Rate	1	1
Defective Component	1	1
No Audible Prompt/Feedback	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	1248	1248
Insufficient Information	484	484
No Consequences Or Impact To Patient	205	205
No Patient Involvement	63	63
Thrombosis/Thrombus	33	33
Cardiac Arrest	15	15
Hemorrhage/Bleeding	11	11
Swelling/ Edema	11	11
Pulmonary Embolism	9	9
Pneumothorax	5	5
Hematoma	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Infiltration into Tissue	3	3
Injury	3	3
No Known Impact Or Consequence To Patient	3	3
Hemothorax	2	2
Fever	2	2
Unspecified Blood or Lymphatic problem	2	2
Cardiac Tamponade	2	2
Obstruction/Occlusion	2	2
Failure of Implant	2	2
Death	2	2
Abdominal Pain	2	2
Pericardial Effusion	1	1
Blister	1	1
Skin Discoloration	1	1
Ventricular Fibrillation	1	1
Abrasion	1	1
Inflammation	1	1
Foreign Body In Patient	1	1
Sepsis	1	1
Hypothermia	1	1
Pain	1	1
Ecchymosis	1	1
Bradycardia	1	1
Sudden Cardiac Death	1	1
Brain Injury	1	1
Shock	1	1
Perforation of Vessels	1	1
Convulsion/Seizure	1	1
Myocardial Infarction	1	1
Stroke/CVA	1	1
Loss of consciousness	1	1
Heart Block	1	1
Air Embolism	1	1
Thrombus	1	1
Vessel Or Plaque, Device Embedded In	1	1

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