TPLC - Total Product Life Cycle

show TPLC since

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	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