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
Display or Visual Feedback Problem	7	7
Complete Loss of Power	7	7
Difficult to Insert	7	7
Detachment of Device or Device Component	7	7
Infusion or Flow Problem	5	5
Material Rupture	5	5
Difficult to Flush	5	5
Display Difficult to Read	5	5
Break	4	4
Backflow	4	4
Material Split, Cut or Torn	4	4
Output Problem	3	3
Gas/Air Leak	3	3
Retraction Problem	3	3
Defective Component	2	2
Positioning Problem	2	2
Material Puncture/Hole	2	2
Crack	2	2
Material Twisted/Bent	2	2
Improper Flow or Infusion	2	2
Excessive Cooling	2	2
Air/Gas in Device	2	2
Appropriate Term/Code Not Available	2	2
No Audible Prompt/Feedback	2	2
Tear, Rip or Hole in Device Packaging	1	1
Material Separation	1	1
Physical Resistance/Sticking	1	1
Electrical Shorting	1	1
Material Protrusion/Extrusion	1	1
Sparking	1	1
Device Alarm System	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
Hematoma	5	5
Pneumothorax	5	5
Thrombosis	4	4
Death	4	4
Infiltration into Tissue	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Vessel Or Plaque, Device Embedded In	3	3
Obstruction/Occlusion	2	2
Cardiac Tamponade	2	2
Unspecified Blood or Lymphatic problem	2	2
Fever	2	2
Abdominal Pain	2	2
Hemothorax	2	2
Failure of Implant	1	1
Inflammation	1	1
Blood Loss	1	1
Chemical Exposure	1	1
Abrasion	1	1
Blister	1	1
Sepsis	1	1
Brain Injury	1	1
Skin Discoloration	1	1
No Code Available	1	1
Ventricular Fibrillation	1	1
Stroke/CVA	1	1
Foreign Body In Patient	1	1
Hypothermia	1	1
Pain	1	1
Ecchymosis	1	1
Bradycardia	1	1
Sudden Cardiac Death	1	1
Air Embolism	1	1
Shock	1	1
Perforation of Vessels	1	1
Convulsion/Seizure	1	1
Myocardial Infarction	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